Z-1253-2023Class II

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Name: Z-1253-2023 In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Creator: BioFire Diagnostics, LLC
Published: 2023-02-01
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-02-01 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 on 2023-02-01. FDA classified it as Class II and gives the reason as "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...". 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-1253-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-15
Recalling firm: BioFire Diagnostics, LLC
Product: In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support
Quantity in commerce: 2 kits
Distribution: U.S. Nationwide distribution in the states of FL and GA.
Product codes and lots: Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15
Z-1252-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15
Z-1253-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15

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)