CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Alinity m HBV AMP Kit (US and CE) recalled by Abbott Molecular
Abbott Molecular is recalling Alinity m HBV AMP Kit (US and CE), distributed in 14 states. The recall was initiated on 4 Mar 2022 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-0884-2022
- FDA event ID
- 89757
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2022
- FDA classified
- 6 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Mar 2022 | Recall initiated by company | |
| 6 Apr 2022 | Classified by FDA | +33 days |
| 13 Apr 2022 | 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
There is a potential for misquantitation high results for negative samples.
Product as listed by the FDA
Alinity m HBV AMP Kit (US and CE)
Where it was distributed
US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
ArizonaCaliforniaIllinoisIndianaMassachusettsMichiganMissouriNew HampshireNew JerseyNew YorkOhioSouth DakotaTexasVirginia
Questions about this recall
Why was it recalled?
There is a potential for misquantitation high results for negative samples.
Which lots are affected?
List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596
Where was it sold?
US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, 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 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 89757| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alinity m HBV Application Specification File (US and CE) recalled | Abbott Molecular | Other | 14 states |
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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