Health product recall

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

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

ALINITY M SARS-COV-2 AMP KIT

Lot or serial number

All lots

Model or catalog number

09N78-090

Companies
Manufacturer
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES

ALINITY M RESP-4 PLEX AMP KIT

Lot or serial number

All lots

Model or catalog number

09N79-090

Companies
Manufacturer
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES