FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
- Recall number
- Z-1451-2020
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
- Status
- Terminated
- Initiated
- 2019-08-08
- Posted
- not on file
- Terminated
- 2022-04-12
- Reason
- Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
- Root cause
- Employee error
- Action
- on August 8, 2019, a "Urgent: Medical Device Recall (Removal)" letter was sent to all affected consignees via FedEx priority-overnight. The notification informed consignees about the recall and asked they take the following actions: Requested Actions: " Please immediately examine your inventory for BioFire GI Panel reagents with kit lot number 0537319. The lot number can be found on the product label outside of the reagent box. " If reagents with the related kit lot number are found, please stop using the affected product, quarantine them, and call BioFire Technical Support to have the product returned. The BioFire Technical Support Team can assist with shipping logistics and provide a replacement. " Complete and return the enclosed Acknowledgement of Receipt Form as soon as possible and return to BioFire via one of the methods listed on the form. " If you have any questions or concerns, please dont hesitate to contact our customer support department at support@biofiredx.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for product technical support.
- Quantity
- 23 kits (690 pouches)
- Distribution
- US: KY, IL, NJ, MS
- Lot, serial or model codes
- Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30
- 510(k) numbers
- ["K140407","K143005","K160459"]
- PMA numbers
- not on file
- Product code
- PCH
- 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