CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report
Alinity m HCV AMP kit, List recalled by Abbott Molecular
Abbott Molecular is recalling Alinity m HCV AMP kit, List (. The recall was initiated on 30 Oct 2023 and the FDA has classified it as Class II.
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-0407-2024
- FDA event ID
- 93230
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2023
- FDA classified
- 29 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Oct 2023 | Recall initiated by company | |
| 29 Nov 2023 | Classified by FDA | +30 days |
| 6 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
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 HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Which lots are affected?
a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447
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.
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 |
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