Kit Cobas 6800/8800 Sars-Cov-2/Flu recall in Canada: performance issue
In plain language
This recall involves the Kit Cobas 6800/8800 Sars-Cov-2/Flu sold in Canada. It's being recalled because of a performance issue that may lead to false negative influenza A results. Contact Roche Diagnostics for more information.
What to do
- Contact Roche Diagnostics if you require additional information.
- This recall is for healthcare professionals.
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Affected products
Kit Cobas 6800/8800 Sars-Cov-2/Flu
Model: 09233474190, 09446125190
Lot: All lots
Why this matters
Performance issue leading to false negative 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: 09233474190, 09446125190
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?
Performance issue leading to false negative results
What should consumers do?
Contact Roche Diagnostics if you require additional information. This recall is for healthcare professionals.
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. Performance issue leading to false negative results
When was this product recalled?
This product was recalled on February 9, 2024.
Is the Roche Molecular Systems, Inc brand affected by this recall?
Yes, Roche Molecular Systems, Inc products are affected by this recall. This recall involves the Kit Cobas 6800/8800 Sars-Cov-2/Flu sold in Canada. It's being recalled because of a performance issue that may lead to false negative influenza A results. Contact Roche Diagnostics for more information.