FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

FDA device recall Z-0994-2024 · posted 2024-02-06 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

Their is a potential for false positive results when using Pneumonia panel.

Action taken

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

Status

Open, Classified

Product code

QBH

Quantity affected

274,290 units

Distribution

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

Date initiated

2023-12-14

Date posted

2024-02-06

Location

Salt Lake City, UT

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