Z-0884-2022Class II

Alinity m HBV AMP Kit (US and CE)

Name: Z-0884-2022 Alinity m HBV AMP Kit (US and CE)
Creator: Abbott Molecular, Inc.
Published: 2022-03-04
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-03-04 / Open, Classified

FDA source

Abbott Molecular, Inc. began a recall of Alinity m HBV AMP Kit (US and CE) on 2022-03-04. FDA classified it as Class II and gives the reason as "There is a potential for misquantitation high results for negative samples". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0884-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-04
Posted: 2022-04-06
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m HBV AMP Kit (US and CE)
Product code: MKT Hepatitis Viral B Dna Detection
Reason for recall: There is a potential for misquantitation high results for negative samples.
FDA root cause: Under Investigation by firm
Action: On March 4, 2022, Abbott Molecular issued an Urgent Field Safety Notice / Field Correction Recall Notice, Urgent Field Safety Notice, and Dear Health Care Provider letter to all customers who received the Alinity m HBV Amp Kits (List Number 08N47-095 Lot Numbers 519756, 523799, 524361 and List Number 08N47-090 Lot Numbers 519755 520957, 522137, 523798, and 524059). Consignees are asked to follow the necessary actions outlined in the letter and complete and return the Customer Reply Form. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. If results are inconsistent with patient history and other diagnostics through patient monitoring, a retest of the same sample should be considered. 100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance. Abbott personnel will follow up with customers by e-mailing and or follow-up visits/phone calls. The firm issued a second Urgent Field Safety Notice / Field Correction Recall notice on 01/13/2023 to consignees that received the newly identified lot numbers: (List Number 08N47-095 Lot Numbers 381583, 529391, 529687, 530273, 531598 and List Number 08N47-090 Lot Numbers 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596).
Quantity in commerce: 4966 kits, updated 101/17/2023
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0884-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0883-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-06
Z-0884-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-06

Product code MKT

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)