Recall Z-1349-2023 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
| Date | Apr 6, 2023 (initiated Nov 11, 2022) |
| Status | Open, Classified |
| Reason | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results. |
| Root cause | Under Investigation by firm |
| Action | The field service engineer installed the missing plunger assembly in the clamp bar while at the consignee location on 11/11/2022. The recalling firm issued the recall letter on 3/1/2023 via overnight mail to their sole consignee. The letter explains the issue, the potential impact, and the necessary actions, which includes placing the impacted ADU out of service and contacting Abbott technical support regarding concerns about the performance of the instrument or results. The letter is to be reviewed with the Medical Director or Laboratory Management and the consignee is to follow their labo |
| Quantity | 1 |
| Distribution | US Distribution to state of: PA, a government account. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.