KIT COBAS LIAT SARS-COV-2/FLU (2021-03-18)

Starting date:

March 18, 2021

Posting date:

April 14, 2021

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-75379

Last updated:
2021-04-14

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  Reason
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  Affected products

Affected Products 

KIT COBAS LIAT SARS-COV-2/FLU

Reason

Roche identified some erroneous results associated with the cobas Sars-CoV-2 and Influenza A/B Test for use on the cobas Liat System. Invalid and/or false positive results could be generated. Review of customer-provided data associated with the reported invalid and false positive results show abnormal PCR growth curves.

Affected products