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Lifecodes Platelet Antibody Screening Kit
- Starting date:
- July 27, 2012
- Posting date:
- September 3, 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-23845
Recalled Products
A. Lifecodes Platelet Antibody Screening Kit
Reason
Anomalous decrease in the average Optical Density (OD) results. During internal testing, the average OD values for the positive control were lower than expected in these lots. In most cases the lower reactivity LED to invalid assay runs. In a few instances the assays were considered valid, but due to the lower than expected reactivity the sensitivity may have been decreased for samples with average OD values near the assay cutoff.
Affected products
A. Lifecodes Platelet Antibody Screening Kit
Lot or serial number
101811P12
Model or catalog number
PAK12
Companies
- Manufacturer
-
Gen-Probe GTI Diagnostics Inc. DBA
Gen-Probe Incorporated