Z-2588-2023Class II

FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

Name: Z-2588-2023 FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Creator: BioFire Diagnostics, LLC
Published: 2023-04-25
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-04-25 / Open, Classified / root cause: software

FDA source

BioFire Diagnostics, LLC began a recall of FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software on 2023-04-25. FDA classified it as Class II and gives the reason as "The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2588-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2024-09-30
Recalling firm: BioFire Diagnostics, LLC
Product: FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Root cause tag: software
FDA root cause: Software design
Action: On 4/25/23 correction notices were mailed to customers who were told to update the GI pouch module software. Instructions for installation can be downloaded here: https://www.biofiredx.com/e-labeling/ITIFA20GI21. This technical note and download cannot be opened via Firefox browser; please use a different browser. Once the pouch module software has been updated, complete and return the webform located at: https://www.biofiredx.com/gisoftware-5747 or return the acknowledgement form via email to [email protected] Questions or concerns can be directed to Technical Support at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5.
Quantity in commerce: 61,069
Distribution: US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZW
Product codes and lots: Model/UDI-DI: RFIT-ASY-0104/00815381020116, RFIT-ASY-0116/00815381020109 using software versions prior to FLM2-SFW-0040 v2.0.3.1/BFS0001-5539 v2.0.200.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2588-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-14

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)