Health product recall

ADIVA Chemistry System - Liquid Specific Protein Calibrators Including Series 1200, 1800 And 2400 (2017-12-08)

Starting date:
December 8, 2017
Posting date:
January 8, 2018
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-65578

Affected Products

A. ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrators

B. ADVIA Chemistry System - Liquid Specific Protein Calibrators

C. ADVIA 1800 Chemistry System - Liquid Specific Protein Calibrators

D. ADVIA 2400 Chemistry System - Liquid Specific Protein Calibrators

Reason

Siemens Healthcare Diagnostics has confirmed that a very small portion of Liquid Specific Protein (LSP) calibrator, Lot # 411508 may contain an empty level 1 vial. The vial is supposed to contain 1 mL of level 1 calibrator material.

Affected products

A. ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrators

Lot or serial number

411508

Model or catalog number

07711199

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES


B. ADVIA Chemistry System - Liquid Specific Protein Calibrators

Lot or serial number

411508

Model or catalog number

07711199

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES


C. ADVIA 1800 Chemistry System - Liquid Specific Protein Calibrators

Lot or serial number

411508

Model or catalog number

07711199

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES


D. ADVIA 2400 Chemistry System - Liquid Specific Protein Calibrators

Lot or serial number

411508

Model or catalog number

07711199

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES