Abbott Molecular, Inc. Alinity m HBV Application Specification File (US and CE) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alinity m HBV Application Specification File (US and CE)
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
List Numbers: 1) 08N47-03A (US), Version 1.00 2) 08N47-01B (CE), Version 2.00 3) 08N47-01C (CE), Version 3.00
Products Sold
List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00
Abbott Molecular, Inc. is recalling Alinity m HBV Application Specification File (US and CE) due to There is a potential for misquantitation high results of negative samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for misquantitation high results of negative samples.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, VA
Page updated: Jan 10, 2026