CLASS I Device recall · Reported 20 Oct 2021 · FDA Enforcement Report
Alinity m Sars-CoV-2 Amp Kit (Non-US Assay) recalled by Abbott Molecular
Abbott Molecular is recalling Alinity m Sars-CoV-2 Amp Kit (Non-US Assay) and Alinity m Sars-CoV-2 Application, distributed nationwide in the US. The recall was initiated on 2 Sep 2021 and the FDA has classified it as Class I.
Check your package
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-0007-2022
- FDA event ID
- 88626
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Sep 2021
- FDA classified
- 14 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Sep 2021 | Recall initiated by company | |
| 14 Oct 2021 | Classified by FDA | +42 days |
| 20 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for false positive results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Where it was distributed
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.
Questions about this recall
Why was it recalled?
There is a potential for false positive results.
Which lots are affected?
List Number: 09N78-091, UDI 00884999049222; Lot/Serial, Expiration: 520596, 06/18/2022; 520952, 07/09/2022; 524054, 10/18/2022; 524965, 10/25/2022; 525462, 12/10/2022; 525768, 12/16/2022; 526708, 01/18/2023; 527842, 02/08/2023; List Number 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo
Where was it sold?
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.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
4 other products · FDA event 88626| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Alinity m Resp-4-Plex AMP Kit (Non-US Assay) recalled | Abbott Molecular | Potency & Assay | Nationwide | |
| CLASS I | Alinity m Sars-CoV-2 Amp Kit (Emergency Use Authorization recalled | Abbott Molecular | Potency & Assay | Nationwide | |
| CLASS I | Alinity m Sars-CoV-2 Amp Kit (Non-US Assay) recalled by Abbott Molecular | Abbott Molecular | Potency & Assay | Nationwide | |
| CLASS I | Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization recalled | Abbott Molecular | Potency & Assay | Nationwide |
More recalls from Abbott Molecular
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | The Alinity m System is designed to automate the steps recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled | Abbott Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled | Abbott Molecular | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |