ALINITY M SARS AMP KIT (2021-09-07)

Starting date:

September 7, 2021

Posting date:

September 17, 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-76443

Last updated:
2021-10-15

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  Reason
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  Affected products

Affected Products

A. ALINITY M SARS-COV-2 AMP KIT

B. ALINITY M RESP-4 PLEX AMP KIT

Reason

Abbott Molecular inc. Has received reports of Alinity M SARS-CoV-2 EUA false positive results. Preliminary investigation has identified that potential carryover in the assay tray may contribute to false positive results. An evaluation of the current mixing protocol used during preparation of the PCR reaction mixture determined the current mixing parameters may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. Because the assay parameters and the presence of the SARS-CoV-2 analyte are similar, Alinity M Resp-4-Plex customers are being included in this communication.

Affected products