FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
- Recall number
- Z-1252-2023
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2023-03-15
- Terminated
- not on file
- Reason
- Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
- Root cause
- Environmental control
- Action
- On 02/01/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of a "Temperature Out of Range" issue with multiple products, as a result from Hurricane Ian (10/2022) Customers are Instructed to: Immediately examine their inventory for product identified in this recall. 1. Discontinue use and discard any remaining product in their possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 2. 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 their receipt of this notification. 3. If customers have further distributed this product, please identify any recipients, and notify them at once of this product recall. For questions or concerns, contact customer support department at biofiresupport@biomerieux.com or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support
- Quantity
- 8 kits
- Distribution
- U.S. Nationwide distribution in the states of FL and GA.
- Lot, serial or model codes
- Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QOF
- 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