Recall Z-0462-2022 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 a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. |
| Root cause | Software design |
| Action | On December 06, 2021 Abbott Molecular issued a Product Recall letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative adjusts the amplification detection clamp height on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls. |
| Quantity | 742 devices |
| Distribution | Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozamb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.