BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Pa
FDA device recall Z-2514-2024 · posted 2024-08-06 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Action taken
- On 07/11/2024, the firm emailed an "URGENT FIELD SAFETY NOTICE" to customers informing them the firm has identified an increased risk of false positive Vibrio/Vibrio Cholerae results when the BIOFIRE GI Panel is used with certain lots of Remel" Cary-Blair transport medium (see Appendix A - Affected Remel" Cary-Blair Lots). Customers are instructed to: -If the BIOFIRE GI Panel is used in conjunction with certain lots of Remel" Cary-Blair (Lot # 743930, 769240, 712258, 782425, 732357, and 742049), positive results for Vibrio/Vibrio Cholerae should be confirmed by another method prior to reporting the test results. -Distribute this information to all appropriate personnel in your laboratory, retain a copy for your files, post this letter in or near the laboratory, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Complete the Acknowledgement Form in Attachment A and return it to usfieldactions@biomerieux.com, so that bioMrieux may acknowledge your receipt of this notification. It is important that you return the acknowledgment form to bioMrieux even if you determine this urgent field safety notice does not impact your facility. For assistance or any questions, contact the bioMrieux Technical Support Center by email at BioFireSupport@biomerieux.com or (800) 682-2666. The anticipated turnaround time for email inquiries is 24 48 hours during normal business hours.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PCH
- Quantity affected
- 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
- Distribution
- U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD,
- Date initiated
- 2024-05-16
- Date posted
- 2024-08-06
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) | Biofire Diagnostics, LLC | 2023-03-16 |
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407) | Biofire Diagnostics | 2014-05-02 |