Class 2 Device Recall FilmArray Gastrointestinal (GI) Panel

• Date Initiated by Firm: March 08, 2023
• Date Posted: April 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1392-2023
• Recall Event ID: 91892
• 510(K)Number: K140407 K143005
• Product Classification: Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
• Product: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
• Code Information: Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109
• Recalling Firm/ Manufacturer: BioFire Diagnostics, LLC; 515 S Colorow Dr; Salt Lake City UT 84108-1248
• For Additional Information Contact: Customer Support Department ; 800-736-6354 Ext. 5
• Manufacturer Reason for Recall: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
• FDA Determined 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 biofiresupport@biomerieux.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PCH and Original Applicant = Biofire Diagnostics; 510(K)s with Product Code = PCH and Original Applicant = BioFire Diagnostics, LLC