FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Recall number
- Z-2440-2023
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-05-08
- Posted
- 2023-08-21
- Terminated
- not on file
- Reason
- Due to manufacturing issue, panels may result in false negative results.
- Root cause
- Process design
- Action
- Between the dates of May 8, 2023 - May 11, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via FedEx. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for product identified in this recall (refer to Table 1). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 3. Please complete the accompanying Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to bioMerieux so that bioMerieux may acknowledge your receipt of this notification. 4. If you have further distributed this product, please identify any recipients, and notify them at once of this product recall. 5. For product replacement, as well as any other questions or concerns, please contact our customer support department at biofiresupport@biomerieux.com or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report online. " Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
- Quantity
- 24 Kits (30 pouches/kit)
- Distribution
- US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
- Lot, serial or model codes
- Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482
- 510(k) numbers
- ["K180966","K212727"]
- PMA numbers
- not on file
- Product code
- QBH
- Firm FEI
- 3002773840
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28