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

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  Reason
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  Affected products

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