Cobas z 480 (2020-12-08)

Starting date:

December 8, 2020

Posting date:

December 18, 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-74565

Last updated:
2020-12-18

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  Reason
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  Affected products

Affected Products

Cobas z 480

Reason

Our manufacturer received a few complaints alleging false positive or invalid results with select cobas 4800 IVD assays. The complaint investigations confirmed the potential for false positive and/or invalid results with IVD assays on cobas z 480 module due to dirty lens.

Affected products