Health product recall

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