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Health product recall

D-10 HAEMOGLOBIN TESTING SYSTEM - HBA1C KIT (2016-01-07)

Starting date:
January 7, 2016
Posting date:
January 25, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56792

Affected Products

D-10 HAEMOGLOBIN TESTING SYSTEM - HBA1C KIT

Reason

On a rare occasion, there is a potential to assign a patient result to an incorrect sample 10 when running in D-10 Rack Loader configuration.

Affected products

D-10 HAEMOGLOBIN TESTING SYSTEM - HBA1C KIT

Lot or serial number
  • DR1E570206
  • DR4A862209
  • DR7D119023
  • DR7J167314
  • DR9A338109
  • DR9D347902
  • DR9G372612
Model or catalog number

2200600

Companies
Manufacturer
Bio-Rad Laboratories Clinical Diagnostics Group
4000 Alfred Nobel Drive
Hercules
94547
California
UNITED STATES