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

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  Reason
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  Affected products

Affected Products

1. ABEL90  Flex Analyzer
2. 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