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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Pneumonia Panel (Pneumo)

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  Class 2 Device Recall FilmArray Pneumonia Panel (Pneumo) see related information
Date Initiated by Firm May 08, 2023
Date Posted August 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2440-2023
Recall Event ID 92397
510(K)Number K180966  K212727  
Product Classification Lower respiratory microbial nucleic acid detection system - Product Code QBH
Product FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Code Information Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Biofire Diagnostics, LLC. Customer Support Dept.
800-736-6354 Ext. 5
Manufacturer Reason
for Recall		 Due to manufacturing issue, panels may result in false negative results.
FDA Determined
Cause 2		 Process design
Action Between the dates of May 8, 2023 - May 11, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via FedEx. 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 24 Kits (30 pouches/kit)
Distribution US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
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 = QBH and Original Applicant = BioFire Diagnostics, LLC
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