CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report

Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular

Abbott Molecular is recalling Abbott Alinity m Resp-4-Plex Amp Kit. The recall was initiated on 22 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;

Quantity recalled12116 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0740-2023
FDA event ID: 91202
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Ongoing
Recall initiated: 22 Nov 2022
FDA classified: 20 Dec 2022
Reported: 28 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Nov 2022	Recall initiated by company
20 Dec 2022	Classified by FDA	+28 days
28 Dec 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Product as listed by the FDA

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Which lots are affected?

Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 91202

This product is part of a recall event; the main page for the event is Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular.

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022	CLASS II	Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular	Abbott Molecular	Other	IL

More recalls from Abbott Molecular

All 36

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled	Abbott Molecular	Other	Nationwide
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled	Abbott Molecular	Other	Nationwide
30 Apr 2025Device	CLASS II	The Alinity m System is designed to automate the steps recalled	Abbott Molecular	Other	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide

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