Abbott Molecular, Inc. recalls 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 clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This…
Read the official notice →- Date
- 2023-04-12
- Country
- United States
- Brand
- Abbott Molecular
- Product
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Classification
- Class II
- Units
- US Distribution to state of: PA, a government account.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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