Health product recall

proBNP II STAT Calset and proBNP II Calibrator (2018-06-14)

Starting date:
June 14, 2018
Posting date:
June 29, 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-67136

Affected products

  1. proBNP II STAT Calset
  2. proBNP II Calibrator

Reason

Increased QC recovery and/or re-calibration issues due to signal drift, when the proBNP II calibrator lots 221122 and 288039 or proBNP STAT Calibrator lots 221133 and 288040 are used after being stored at 2-8 degrees Celsius after reconstitution.

Affected products

A. proBNP II STAT Calset

Lot or serial number
  • 22113301
  • 28804001
Model or catalog number
  • 05390117190
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


B. proBNP II Calibrator

Lot or serial number
  • 22112201
  • 22112202
  • 28803901
Model or catalog number
  • 04842472190
Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY