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ProTime 3 Cuvettes
- Starting date:
- October 15, 2012
- Posting date:
- October 29, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15149
Recalled Products:
ProTime 3 Cuvettes
Reason
International Technidyne Corp., has determined that some ProTime 3 test cuvettes (Pro3-25) within a specified lot range may recover lower than expected prothrombin time/international normalized ratio (Pt/Inr) results.
Affected products
ProTime 3 Cuvettes
Lot or serial number
- A2P3C001 / A2K3C001 (kit)
- B2P3C033 / B2K3C033 (kit)
- C2P3C048 / C2K3C048 (kit)
- C2P3C054 / C2K3C054 (kit)
- D2P3C078 / D2K3C078 (kit)
Model or catalog number
PRO3-25
Companies
- Manufacturer
- International Technidyne Corp.