Z-1451-2020Class II

FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx...

Name: Z-1451-2020 FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx...
Creator: BioFire Diagnostics, LLC
Published: 2019-08-08
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2019-08-08 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only on 2019-08-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1451-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-08
Posted: 2020-03-06
Terminated: 2022-04-12
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5 for product technical support.
Quantity in commerce: 23 kits (690 pouches)
Distribution: US: KY, IL, NJ, MS
Product codes and lots: Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1451-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1451-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-06

Product code PCH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)