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Health product recall

D-10 Haemoglobin Testing System - Dual Program (HBA2/E/AIC) (2013-12-19)

Starting date:
December 19, 2013
Posting date:
January 17, 2014
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-37591

Recalled products

  1. D-10 Haemoglobin Testing System - Dual Program (HBA2/E/AIC) 

Reason

The number of injections did not increase while using the D-10 dual short program and the extended program on the D-10 Haemoglobin Testing System.

Affected products

A. D-10 Haemoglobin Testing System - Dual Program (HBA2/E/AIC)

Lot or serial number
  • 64000331
  • 64000888
  • 64002239
Model or catalog number
  • 220-0201
Companies
Manufacturer
Bio-Rad Laboratories Clinical Diagnostics Group
4000 Alfred Nobel Drive
Hercules
94547
California
UNITED STATES