FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Alinity m HBV AMP Kit (US and CE)
- Recall number
- Z-0884-2022
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Alinity m HBV AMP Kit (US and CE)
- Status
- Open, Classified
- Initiated
- 2022-03-04
- Posted
- 2022-04-06
- Terminated
- not on file
- Reason
- There is a potential for misquantitation high results for negative samples.
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P200013"]
- Product code
- MKT
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28