Recall StatusOpen, Classified
Date Initiated2023-12-14
Product Quantity274,290 units
Reason for Recall
Their is a potential for false positive results when using Pneumonia panel.
Firm Action
On December 14, 2023, Biomerieux, issued a "Urgent Medical Recall" to affected consignees via: FedEx . Biomerieux asked consignees to take the following actions:
1. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.
2. Use another method to confirm positive results for seasonal Coronavirus from the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus prior to reporting the result (e.g., consider results from testing a nasopharyngeal swab with a different BIOFIRE respiratory panel such as the BIOFIRE Respiratory Panel 2.1). Alternatively, the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus seasonal Coronavirus positive result should not be reported.
3. Complete the Acknowledgement Form in Attachment A (on the following page) and return it to bioMrieux to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this urgent product correction notice does not impact your facility.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.