ABL800 FLEX Analyzer (2020-05-07)

Starting date:

May 7, 2020

Posting date:

November 20, 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-74343

Last updated:
2020-11-19

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  Reason
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  Affected products

Affected Products

ABL800 FLEX Analyzer

Reason

Radiometer Medical ApS has received two complaints from the same customer were the customer reports that they have experienced patient data mix up when using ABL800 with FLEXQ. Investigation has shown that a software bug caused the incidents. The mix-up will only occur if the analyzer is setup in a specific manner and a specific sequence of events occurs. Please see attached Health Hazard Evaluation for further information.

Affected products