Biofire® Blood Culture Identification 2 recall in Canada: Performance issue
In plain language
This recall involves Biofire® Blood Culture Identification 2 (BCID2) sold in Canada. It's being recalled because of an increased risk of false positive results for candida tropicalis. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Contact Biomérieux for additional assistance or questions.
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Affected products
Biofire® Blood Culture Identification 2 (BCID2)
Model: RFIT-ASY-0147
Lot: 2278923, 2086722, 1611723, 2025922, 2502223, 1785622, 2146723, 2500523, 0798022, 2067123
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: 2278923, 2086722, 1611723, 2025922, 2502223, 1785622, 2146723, 2500523, 0798022, 2067123
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: RFIT-ASY-0147
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 and lot numbers. Contact Biomérieux for additional assistance or questions.
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 23, 2024.
Is the Biofire Diagnostics, LLC. brand affected by this recall?
Yes, Biofire Diagnostics, LLC. products are affected by this recall. This recall involves Biofire® Blood Culture Identification 2 (BCID2) sold in Canada. It's being recalled because of an increased risk of false positive results for candida tropicalis. Stop using the product and follow the return/repair steps in the official notice.