Biofire® Respiratory Panel 2.1 (Rp2.1)
Brand(s)
Last updated
Summary
Product
Biofire® Respiratory Panel 2.1 (Rp2.1)
Issue
Medical devices - Performance issue
What to do
Contact the importer, Biomerieux Canada Inc.
Audience
Healthcare
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Biofire® Respiratory Panel 2.1 (Rp2.1) | 2168222 | 423742 |
Issue
Biomerieux identified a manufacturing event that may contribute to elevated rates of false negative results while using the Biofire RP2.1 panel. Biomerieux has not received any false negative complaints from the field but, out of an abundance of caution, Biomerieux is recalling the product that was manufactured during this event.
Recall start date: May 16, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
Biofire Diagnostics, LLC.
515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73737
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