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I-Stat Analyzer Software and Cartridges (2017-02-10)
- Starting date:
- February 10, 2017
- Posting date:
- March 16, 2017
- 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-62646
Affected Products
A. I-Stat 1 Analyzer Software
B. I-Stat Kaolin Act Cartridges
C. I-Stat Celite Act Cartridges
Reason
Abbott Point of Care Inc. (APOC) has determined that Celite Act and Kaolin Act Cartridges may produce falsely low results when very high clotting time samples are tested. Patient samples with a measured clot time of >853 seconds for Celite and >1134 seconds for Kaolin may display results of approximately 100 to 200 seconds while using JAMS142E. The typical therapeutic range of the J-stat act assay is 200 to 600 seconds.
Affected products
A. I-Stat 1 Analyzer Software
Lot or serial number
JAMS142E
Model or catalog number
03P75-06
04P75-01
06F16-10
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES
B. I-Stat Kaolin Act Cartridges
Lot or serial number
JAMS142E
Model or catalog number
03P75-06
04P75-01
06F16-10
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES
C. I-Stat Celite Act Cartridges
Lot or serial number
JAMS142E
Model or catalog number
03P75-06
04P75-01
06F16-10
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES