Z-0884-2022 Class II Ongoing
FDA device recall Z-0884-2022 was initiated by Abbott Molecular, Inc. on March 4, 2022 and is designated Class II. Reason for recall: There is a potential for misquantitation high results for negative samples. The recall status is ongoing. Affected quantity: 4966 kits, updated 101/17/2023.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- March 4, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4966 kits, updated 101/17/2023
Product Description
Alinity m HBV AMP Kit (US and CE)
Reason for Recall
There is a potential for misquantitation high results for negative samples.
Distribution Pattern
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
Code Information
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