[Recalled] Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. — The instrument was found to be installed without plunger assemblies in the clam… | FDA 2022-11-11
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. |
|---|---|
| Brand / manufacturer | Abbott Molecular, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1349-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 November 2022 |
| EAN / barcode | 00884999048034 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Abbott Molecular, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.