Abbott Alinity m System recall
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Why was Abbott Alinity m System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.
- Product
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 1
- Distribution
- US Distribution to state of: PA, a government account.
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)