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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire Blood Culture Identification 2 (BCID2) Panel

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  Class 2 Device Recall BioFire Blood Culture Identification 2 (BCID2) Panel see related information
Date Initiated by Firm May 10, 2021
Create Date June 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-1903-2021
Recall Event ID 87934
510(K)Number K193519  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Code Information Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
Recalling Firm/
Manufacturer
BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Customer Support Department
801-736-6354 Ext. 360
Manufacturer Reason
for Recall
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
FDA Determined
Cause 2
Process control
Action On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scrapped (if any) on the attached acknowledgement of receipt form. 4. If you may have further distributed this product, please identify any recipients and notify them at once of this product recall. 5. Please complete the accompanying Field Action acknowledgement of receipt Form and return to BioFire so that BioFire may acknowledge your receipt of this notification. 6. If you have any questions or concerns, please contact our customer support department at support@biofiredx.com or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.
Quantity in Commerce 870 kits
Distribution US nationwide distribution
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 = PEN and Original Applicant = BioFire Diagnostics, LLC
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