ABEL90 Flex Analyzer & ABL90 Flex Plus (2020-01-15)
- Starting date:
- January 15, 2020
- Posting date:
- February 14, 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-72317
Last updated: 2020-02-14
Affected Products
- ABEL90 Flex Analyzer
- ABL90 Flex Plus
Reason
Radiometer has received a few reports of occurrences where the ABL90 barcode reader has misinterpreted the contents of a barcode for patient ID or accession number used for e.g. Sampler identification. The occurrences relate to barcode types not using a check digit, which have been printed locally. A check digit enables the barcode reader to validate the data read by calculating the checksum, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data.
Affected products
A. ABEL90 Flex Analyzer
Lot or serial number
Software version below V3.4MR2.
Model or catalog number
393-090
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK
B. ABL90 Flex Plus
Lot or serial number
Software version below V3.4MR2.
Model or catalog number
393-092
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK