Optilite Analyser (2020-04-09)

Starting date:

April 9, 2020

Posting date:

May 1, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72943

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

Optilite  Analyser

Reason

A software issue has been identified which may affect Optilite Analysers running software versions 7.0 Or 7.0.1. The software bug is not assay specific and if it occurs, it may cause a result to be calculated against a previously validated, although historical calibration curve for the affected assay.

Affected products