Recall Z-0460-2022 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 | Open, Classified |
| Reason | There is a potential for abnormal (non-sigmoidal) amplification curves. |
| Root cause | Under Investigation by firm |
| Action | On December 06, 2021 Abbott Molecular issued a Product Correction 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 customers clamp bar. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls. |
| Quantity | 742 devices |
| Distribution | Worldwide distribution - US Nationwide 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, Mozambiq |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.