ABL90 Flex - Analyzer and ABL90 Flex Plus (2019-11-07)
- Starting date:
- November 7, 2019
- Posting date:
- January 6, 2020
- 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-71979
Last updated: 2020-01-07
Affected Products
A. ABL90 Flex - Analyzer
B. ABL90 Flex Plus
Reason
Radiometer has become aware that the some ABL90 Flex and ABL90 Flex Plus Analyzers may be reporting biased results for bilirubin due to a defect in the hemolyzer unit.
Affected products
A. ABL90 Flex - Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
393-090
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK
B. ABL90 Flex Plus
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
393-092
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK