I-STAT CARTRIDGE (2020-12-22)
- Starting date:
- December 22, 2020
- Posting date:
- January 15, 2021
- 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-74757
Last updated:
2021-01-15
Affected Products
A. I-STAT CG8+ CARTRIDGE
B. I-STAT EG7+ CARTRIDGE
Reason
Abbott Point of Care has determined through an internal study that the ionized calcium on some i-Stat CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30°C) for periods of time in excess of 3- or 7-days dependent on the cartridge lot number.
Affected products
A. I-STAT CG8+ CARTRIDGE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03P88-25
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES
B. I-STAT EG7+ CARTRIDGE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03P76-25
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES