Z-0008-2022Class I

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in...

Name: Z-0008-2022 Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in...
Creator: Abbott Molecular, Inc.
Published: 2021-09-02
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2021-09-02 / Terminated / root cause: design

FDA source

Abbott Molecular, Inc. began a recall of Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic on 2021-09-02. FDA classified it as Class I and gives the reason as "There is a potential for false positive results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0008-2022
Classification: Class I
Status: Terminated
Initiated: 2021-09-02
Posted: 2021-10-14
Terminated: 2024-07-23
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: There is a potential for false positive results.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an Urgent Field Safety Notice/Field Correction Recall 09/02/2021 to all impacted customers. Per the customer letter, all positives are to be considered presumptive until the Alinity m SARS-CoV-2 Application Specification file version 5 or the updated Alinity m Resp-4-Plex Application Specification file is implemented at the customer site. On 03/30/2022, Abbott Molecular issued a follow-up Urgent Field Safety Notice/Field Correction Recall letter to all customers who ordered Alinity m SARS-CoV-2 AMP Kit Emergency Use Authorization (EUA), List Number 09N78-095 and/or Alinity m Resp-4-Plex AMP Kit EUA, List Number 09N79-096 used with the Alinity m System. Also to customers who ordered Alinity m SARS-CoV-2 AMP Kit (CE), List Number 09N78-090 or 09N78-091 and/or Alinity m Resp-4-Plex AMP Kit (CE), List Number 09N79-090 used with the Alinity m System. The Customer Letter explains Abbott has updated the existing Application Specification files for Alinity m SARS-CoV-2 and Resp-4-Plex to further reduce the potential for carryover. FDA has not yet authorized the Alinity m SARS-CoV-2 Application Specification file version 6 update or the Alinity m Resp-4-Plex Application Specification file version 5 update. Implementation of the modification for Alinity m SARS-CoV-2 and Resp-4-Plex will occur when the update to the Application Specification file has been authorized. A Molecular Diagnostics Abbott Representative will be contacting you once the updated Application Specification files are available. If you have any questions, please contact your local Molecular Diagnostics Abbott representative or call Abbott Technical Support at 1-800-553-7042 Option 2.
Quantity in commerce: 5855 units
Distribution: Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
Product codes and lots: List Number: 09N79-096, UDI 00884999049390 Lot/Serial, Expiration: 513424, 10/13/2021; 513771, 10/13/2021; 513861, 11/06/2021; 514503, 11/19/2021; 515652, 12/02/2021; 516411, 11/06/2021; 517877, 12/02/2021; 518436, 12/10/2021; 518877, 12/10/2021; 519091, 11/06/2021; 519243, 05/10/2022; 519582, 05/10/2022; 519969, 05/10/2022; 520356, 05/10/2022; 520695, 07/08/2022; 522088, 08/04/2022; 522128, 08/26/2022; 523152, 10/10/2022; 524433, 01/15/2023; 526710, 01/21/2023; 527845, 02/08/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0008-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0004-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14
Z-0005-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14
Z-0006-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14
Z-0007-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14
Z-0008-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)