Health product recall

Roche Diagnostics Products (HITACHI, COBAS INTEGRA) (2019-01-14)

Starting date:
January 14, 2019
Posting date:
March 22, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69374

Affected Products

  1. HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)
  2. HITACHI Inorganic Phosphorus (Phos)
  3. HITACHI Bicarbonate (917,P)
  4. HITACHI Alpha-Amylase Liquid ACC. to IFCC (Amyl)
  5. COBAS INTEGRA phosphate (inorganic) ver.2 (Phos2)
  6. COBAS INTEGRA Bicarbonate Liquid (CO2-L)
  7. COBAS INTEGRA Uric Acid Ver.2 (UA2)
  8. COBAS INTEGRA Alpha-Amylase EPS Ver.2 (AMYL2)
  9. COBAS INTEGRA Creatinine Plus Ver.2 (CREP2)
  10. COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)
  11. HITACHI pancreatic-Alpha-Amylase Liquid (P-AMYL)
  12. HITACHI Total Protein in Urine/Cerebrospinal Fluid (U/CSF Protein)
  13. HITACHI Gluco-Quant Glucose HK
  14. HITACHI Uric Acid Plus (UA Plus)
  15. HITACHI Creatinine Plus (CREA plus)
  16. HITACHI Bicarbonate Liquid Unisys
  17. COBAS INTEGRA Glucose HK Gen.3
  18. COBAS INTEGRA Tina-Quant Albumin Gen.2
  19. COBAS INTEGRA Creatinine Jaffe Gen.2
  20. HITACHI Tina-quant Albumin Modular P Antigen Excess Reagent (AlbuXS)
  21. HITACHI Fructosamine (Fruc)
  22. COBAS INTEGRA Fructosamine
  23. COBAS INTEGRA Total Protein Urine/CSF Gen.3 (TPUC3)
  24. Ethanol Gen.2 (EtOH2) For COBAS INTEGRA And COBAS C Systems
  25. C-Reactive Protein Gen.3 (CRPL3)
  26. Albt2 (Tina-quant Albumin Gen. 2) For COBAS C701 Analyzer
  27. Amy-P (Alpha-Amylase EPS Pancreatic) For COBAS C701 Analyzer
  28. Amyl2 (Alpha-Amylase EPS Ver.2) For COBAS C701 Analyzer
  29. Phos2 (Phosphate (Inorganic) Ver.2) For COBAS C701 Analyzer
  30. CO2-L (Bicarbonate Liquid) For COBAS C701 Analyzer
  31. Crej2 (Creatinine Jaffe Gen.2) For COBAS C701 Analyzer
  32. Crep2 (Creatinine Plus Ver.2) For COBAS C701 Analyzer
  33. Gluc3 (Glucose HK Gen.3) For COBAS C701 Analyzer
  34. CRPL3 (C-Reactive Protein Gen.3) For COBAS C701 Analyzer
  35. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
  36. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
  37. Fra (Fructosamine) For COBAS C701 Analyzer
  38. EtOH2 (Ethanol Gen. 2) For Roche / HITACHI COBAS C / Cobas C 701
  39. Mg2
  40. Mg
  41. Ca2 (Calcium Gen.2)

Reason

During introduction of a new platform, manufacturer assessed potential risk of endogenous and drug interferences on all Roche tests and corresponding platforms. New endogenous and individual drug interferences were identified for some ClinChem and HIA assays in serum/plasma, urine and CSF used on COBAS c311, c501, c502, c701 and c702 modules.

Affected products

A. HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11875418216
  • 11875663216
  • 11929941216
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


B. HITACHI Inorganic Phosphorus (Phos)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11730347216
  • 11875965216
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


C. HITACHI Bicarbonate (917,P)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3289907190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


D. HITACHI Alpha-Amylase Liquid ACC. to IFCC (Amyl)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11876473316

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


E. COBAS INTEGRA phosphate (inorganic) ver.2 (Phos2)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3183793122

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


F. COBAS INTEGRA Bicarbonate Liquid (CO2-L)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3289923190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


G. COBAS INTEGRA Uric Acid Ver.2 (UA2)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3183807190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


H. COBAS INTEGRA Alpha-Amylase EPS Ver.2 (AMYL2)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3183742122

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


I. COBAS INTEGRA Creatinine Plus Ver.2 (CREP2)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3263991190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


J. COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

20766623322

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


K. HITACHI pancreatic-Alpha-Amylase Liquid (P-AMYL)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11876562316

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


L. HITACHI Total Protein in Urine/Cerebrospinal Fluid (U/CSF Protein)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11877801190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


M. HITACHI Gluco-Quant Glucose HK

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11876899216
  • 11929534216
  • 11929542216
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


N. HITACHI Uric Acid Plus (UA Plus)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11929429216
  • 11929437216
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


O. HITACHI Creatinine Plus (CREA plus)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11875566216
  • 11875582216
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


P. HITACHI Bicarbonate Liquid Unisys

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3289885190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


Q. COBAS INTEGRA Glucose HK Gen.3

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4404483190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


R. COBAS INTEGRA Tina-Quant Albumin Gen.2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4469658190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


S. COBAS INTEGRA Creatinine Jaffe Gen.2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4810716190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


T. HITACHI Tina-quant Albumin Modular P Antigen Excess Reagent (AlbuXS)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4999622190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


U. HITACHI Fructosamine (Fruc)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11930010216

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


V. COBAS INTEGRA Fructosamine

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4537939190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


W. COBAS INTEGRA Total Protein Urine/CSF Gen.3 (TPUC3)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3333825190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


X. Ethanol Gen.2 (EtOH2) For COBAS INTEGRA And COBAS C Systems

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

3183777190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


Y. C-Reactive Protein Gen.3 (CRPL3)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 4956842190
  • 4956885190
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


Z. Albt2 (Tina-quant Albumin Gen. 2) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5167043190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AA. Amy-P (Alpha-Amylase EPS Pancreatic) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5167035190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AB. Amyl2 (Alpha-Amylase EPS Ver.2) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5167027190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AC. Phos2 (Phosphate (Inorganic) Ver.2) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5171377190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AD. CO2-L (Bicarbonate Liquid) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5446376191

6407102190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AE. Crej2 (Creatinine Jaffe Gen.2) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

6407137190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AF. Crep2 (Creatinine Plus Ver.2) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5168589190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AG. Gluc3 (Glucose HK Gen.3) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5168791190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AH. CRPL3 (C-Reactive Protein Gen.3) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5172373190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AI. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5171954190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AJ. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5171857190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AK. Fra (Fructosamine) For COBAS C701 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5171962190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AL. EtOH2 (Ethanol Gen. 2) For Roche / HITACHI COBAS C / Cobas C 701

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5967104190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AM. Mg2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

6407358190

6481647190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AN. Mg

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11551353216

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


AO. Ca2 (Calcium Gen.2)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5061431190

5061458190

5061482190

5168449190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY