i-STAT CHEM8+ Cartridges and Controls (2018-06-05)
- Starting date:
- June 5, 2018
- Posting date:
- June 14, 2018
- 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-67044
Affected products
i-STAT CHEM8+ Cartridges and Controls
Reason
Abbott Point Of Care Inc. (APOC) has determined that when testing the listed CHEM8+ Cartridge lots with i-STAT TriControls fluids, elevated sodium results may be generated. The frequency of sodium results generated outside package insert limits as found on Value Assignment Sheets (VAS) or Electronic Value Assignment Sheets (EVAS) may be higher than usual.
Affected products
i-STAT CHEM8+ Cartridges and Controls
Lot or serial number
H18089E
H18090
H18090A
H18091B
Model or catalog number
09P31-25
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES