ALINITY M SARS AMP KIT recall in Canada: False positive results
In plain language
This recall involves the ALINITY M SARS-COV-2 AMP KIT and ALINITY M RESP-4 PLEX AMP KIT sold in Canada. They are being recalled because of potential false positive results due to carryover in the assay tray. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return or dispose of it as instructed.
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Affected products
ALINITY M SARS-COV-2 AMP KIT
Model: 09N78-090
Lot: All lots
ALINITY M RESP-4 PLEX AMP KIT
Model: 09N79-090
Lot: All lots
Why this matters
False positive 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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 09N78-090, 09N79-090
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?
False positive test results
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return or dispose of it as instructed.
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. False positive test results
When was this product recalled?
This product was recalled on September 17, 2021.
Is the ALINITY M brand affected by this recall?
Yes, ALINITY M products are affected by this recall. This recall involves the ALINITY M SARS-COV-2 AMP KIT and ALINITY M RESP-4 PLEX AMP KIT sold in Canada. They are being recalled because of potential false positive results due to carryover in the assay tray. Stop using the product and follow the return steps in the official notice.