Abbott Molecular, Inc. Recall 89757
Description: Alinity m HBV AMP Kit (US and CE)
Abbott Molecular, Inc. Recall 89757 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0884-2022 |
| Event ID | 89757 |
| Event Description | Alinity m HBV AMP Kit (US and CE) |
| Product Type | Devices |
| 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 |
| Quantity | 4966 kits, updated 101/17/2023 |
| Recall Reason | There is a potential for misquantitation high results for negative samples. |
| Device Classification | 20220413 |
| Device 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 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220304 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | Letter |
| Similar To |