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I-Stat 1 Analyzer System - PT/LNR Cartridge and Controls (2013-10-28)
- Starting date:
- October 28, 2013
- Posting date:
- December 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36981
Recalled products
A. I-Stat 1 Analyzer System - PT/LNR Cartridge and Controls
Reason
Abbott Point of Care has determined that I-stat PT/INR cartridges have the potential to exhibit incorrectly elevated results. Internal studies have demonstrated that I-stat PT/INR results are elevated by an average of approximately 10% as compared to the international reference preparation (RTF/09) in the therapeutic range of 1.8 to 3.0 INR.
Affected products
A. I-Stat 1 Analyzer System - PT/LNR Cartridge and Controls
Lot or serial number
- C13139 to C13270A
- R13149A
- R13151
- R13151A
Model or catalog number
- 03P89-24
- 04J50-01
- 04J50-02
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES