Alinity m HBV AMP Kit (US and CE)
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- March 4, 2022
- Posted
- April 6, 2022
- Recall Number
- Z-0884-2022
- Quantity
- 4966 kits, updated 101/17/2023
- Firm Location
- Des Plaines, IL
Reason for Recall
There is a potential for misquantitation high results for negative samples.
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 / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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).