Alinity M Resp-4-Plex Amplification Kit recall in Canada: performance issues
In plain language
This recall involves the Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce) sold in Canada. It's being recalled because of potential false positive results for flu B and RSV, and delayed results. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Check the lot and model numbers.
- Contact the manufacturer for additional information.
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Affected products
Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Model: 03R1120, 03R1130, 506-10, 506-30
Lot: 526393, 525766, 381177, 527142, 525460, 531612, 526483, 527602, 527403
Why this matters
Inaccurate test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 526393, 525766, 381177, 527142, 525460, 531612, 526483, 527602, 527403
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 03R1120, 03R1130, 506-10, 506-30
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Inaccurate test results
What should consumers do?
Stop using the product immediately. Check the lot and model numbers. Contact the manufacturer for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on December 14, 2022.
Is the Abbott Molecular Inc. brand affected by this recall?
Yes, Abbott Molecular Inc. products are affected by this recall. This recall involves the Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce) sold in Canada. It's being recalled because of potential false positive results for flu B and RSV, and delayed results. Stop using the product and contact the manufacturer for more information.