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Health product recall

Biotestcell P3

Starting date:
September 12, 2012
Posting date:
October 1, 2012
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-15132

Recalled Products

A. Biotestcell P3

Reason

The Biotestcell P3 are reagent red blood cells with polyvalent antigens of three single blood donors packaged in 3 separate vials for the detection of red cell antiobodies. The manufacturer received one complaint about an incorrectly labeled vial within the package. Normally, the vials come numbered P1, P2, P3. In this case the package contained 1 bottle of P1 and 2 bottles of P2.

Affected products

A. Biotestcell P3

Lot or serial number

2225011

Model or catalog number

816 017

Companies
Manufacturer
BioRad Medical Diagnostics GMBH