Recall Z-1518-2022 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Abbott Molecular, Inc.
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
| Date | Jul 19, 2022 |
| Status | Completed |
| Reason | Incorrect optical calibration |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument. The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022. The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference. |
| Quantity | 1 |
| Distribution | There was only foreign distribution to Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.