Recall Z-1349-2023— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-11-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.. 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..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-11
- Firm location
- Des Plaines, IL, United States
Product description
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.