Health product recall

Biofire® Respiratory Panel 2.1 (Rp2.1)

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