Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Reported: April 12, 2023 Initiated: November 11, 2022 #Z-1349-2023
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.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 1
- Distribution
- US Distribution to state of: PA, a government account.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.. Recalled by Abbott Molecular, Inc.. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1349-2023.
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