Cobas 6500 - Cobas U Cuvette (2017-09-14)

Starting date:

September 14, 2017

Posting date:

February 22, 2018

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-66022

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  Reason
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  Affected products

Affected products

Cobas 6500 - Cobas U Cuvette

Reason

There is a potential contamination of the cuvettes of the Cobas U Cuvette which may lead to false positive result for the parameter bacteria (bac) on the Cobas U701 microscopy analyzer. Only lot 16483701 is affected by this issue.

Affected products