BioFire? FilmArray? Blood Culture Identification (BCID) Panel (2021-01-27)
In plain language
This recall involves the BioFire FilmArray Blood Culture Identification (BCID) Panel sold in Canada. It's being recalled because it may produce false positive results for Pseudomonas aeruginosa. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers RFIT-ASY-0126 and RFIT-ASY-0127.
- Contact BioFire Diagnostics for further instructions.
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Affected products
BioFire FilmArray Blood Culture Identification (BCID) Panel
Model: RFIT-ASY-0126, RFIT-ASY-0127
Lot: All lots
Why this matters
False positive 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: RFIT-ASY-0126, RFIT-ASY-0127
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 results
What should consumers do?
Stop using the product immediately. Check model numbers RFIT-ASY-0126 and RFIT-ASY-0127. Contact BioFire Diagnostics for further instructions.
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 results
When was this product recalled?
This product was recalled on February 12, 2021.
Is the BioFire brand affected by this recall?
Yes, BioFire products are affected by this recall. This recall involves the BioFire FilmArray Blood Culture Identification (BCID) Panel sold in Canada. It's being recalled because it may produce false positive results for Pseudomonas aeruginosa. Stop using the product and follow the return/repair steps in the official notice.