Health product recall

ABL 80 Flex & Flex CO-OX Flex CO-OX OSM (2020-04-26)

Starting date:
April 26, 2020
Posting date:
May 22, 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-73151



Last updated: 2020-05-22

Affected Products

A. ABL 80 Flex

B. Flex CO-OX  Flex CO-OX OSM

Reason

Radiometer has received reports of occurrences on devices similar to the ABL80 where 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. ABL 80 Flex

Lot or serial number

303997

304204

304327

305554

305558

308594

310566

310578

393-839L300734

393-839L300774

Model or catalog number

393-839

Companies
Manufacturer

Radiometer Medical Aps

Akandevej 21

Bronshoj

2700

DENMARK


B. Flex CO-OX  Flex CO-OX OSM

Lot or serial number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

Radiometer Medical Aps

Akandevej 21

Bronshoj

2700

DENMARK