Recall Z-0463-2022 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
| Date | Dec 6, 2021 |
| Status | Terminated |
| Reason | There is an issue with the installation of updated camera firmware on the system. |
| Root cause | Software design |
| Action | On December 06, 2021 Abbott Molecular issued a Product Correction letter to all customers who received an Alinity m instrument impacted by this issue (List Number 08N53 002). Customers are being informed of a previously completed assessment conducted by Abbott FSEs. Customers were initially informed at the time of the assessment, but proper reconciliation of the communication was not performed. 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 ma |
| Quantity | 74 devices |
| Distribution | Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.