Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray GI Panel

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall FilmArray GI Panel see related information
Date Initiated by Firm February 01, 2023
Date Posted March 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1253-2023
Recall Event ID 91647
510(K)Number K140407  K143005  K160459  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product In Vitro Diagnostic (IVD) Panel

FilmArray GI Panel - REF RFIT-ASY-0116
Code Information Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
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 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.
FDA Determined
Cause 2		 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 biofiresupport@biomerieux.com 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.
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
-
-