Optilite Low Level Albumin Kit (2019-12-19)

Starting date:

December 19, 2019

Posting date:

January 10, 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-72081

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

Optilite Low Level Albumin Kit

Reason

An internal complaint was raised by a TBS member of staff regarding an error in the barcodes on the product Quality Control certificate provided with the affected kit lot (complaint raised 29/NOV/19). This error presents differently depending on the software version the Optilite instrument is running. The Optilite software version 7 barcodes cannot be used, scanning these will give an error message which cannot be overridden. The Optilite software version 6.0.1 barcodes may lead to an intermittent error message, however this message does not affect the performance of the kit. Users running Optilite version 7 software may scan the software version 6.0.1 barcodes in order to use the affected kit.

Affected products