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Platelet Antibody Screening Kit
- Starting date:
- August 15, 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 (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15537
Recalled Products
A. Platelet Antibody Screening Kit
Reason
The manufacturer, Gen-Probe GTI diagnostics, has recently received 2 complaints of decreases in the average Optical Density (OD) of the positive control. This reduction in average OD can cause the positive control values to be too low for a valid assay. Since the decrease in positive control OD lead to invalid assays, the manufacturer has decided to voluntarily withdraw the affected lot from the market.
Affected products
A. Platelet Antibody Screening Kit
Lot or serial number
030112-P12G
Model or catalog number
PAK12G
Companies
- Manufacturer
- Gen-Probe Incorporated, Gen-Probe GTI Diagnostics Inc. DBA