Z-1392-2023Class II

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Name: Z-1392-2023 FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Creator: BioFire Diagnostics, LLC
Published: 2023-03-08
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-03-08 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) on 2023-03-08. FDA classified it as Class II and gives the reason as "Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1392-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-08
Posted: 2023-04-14
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On March 8, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. In addition, to notifying affected consignees about the recalled device, 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 [email protected] 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 in commerce: 900 pouches (30 kits)
Distribution: US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
Product codes and lots: Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)