Date Initiated by Firm |
February 01, 2023 |
Date Posted |
March 15, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1251-2023 |
Recall Event ID |
91647 |
510(K)Number |
K193519
|
Product Classification |
Gram-Negative bacteria and associated resistance markers - Product Code PEN
|
Product |
In Vitro Diagnostic (IVD) Panel
BioFire BCID2 Panel - REF RFIT-ASY-0147 |
Code Information |
Part Number: RFIT-ASY-0147
UDI: 0815381020338
Pouch Lot Number: 1766022 |
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
|
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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
|