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Health product recall

VARIANT II HEMOGLOBIN TESTING SYSTEM(2015-08-24)

Starting date:
August 24, 2015
Posting date:
October 8, 2015
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-55274

Affected Products

  1. VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER
  2. VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
  3. VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

Reason

Complaints have been received regarding a problem with liquid leaking into the dilution chamber, owing to the build-up of back pressure in these devices. If the internal or external liquid discharge tube is blocked or pinched, the back pressure builds up and can cause liquid to leak into the dilution chamber. To prevent potential exposure to liquid waste, it is important to follow the instructions and recommendations set out in the user's guide.

Affected products

  1. VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER

Lot or serial number

All lots.

Model or catalog number
  • 2702000
  • 2702001
Companies
Manufacturer
Bio-Rad Laboratories Clinical Diagnostics Group
4000 Alfred Nobel Drive
Hercules
94547
California
UNITED STATES

B. VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

Lot or serial number

All lots.

Model or catalog number

270-2600

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

C. VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

Lot or serial number

All lots.

Model or catalog number

270-2601

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

Date modified: