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Class 2 Device Recall BioFire Respiratory Panel 2.1 (RP2.1) |
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| Date Initiated by Firm |
May 08, 2023 |
| Date Posted |
August 21, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2439-2023 |
| Recall Event ID |
92397 |
| Product Classification |
Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
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| Product |
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only |
| Code Information |
Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23,
Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23,
Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23,
Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23,
Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23,
Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23,
Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23,
Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23,
Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23,
Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23,
Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23,
Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23,
Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23,
Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23,
Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23,
Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23,
Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23,
Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23,
Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23,
Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23,
Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23,
Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23,
Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23,
Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23,
Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23,
Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23,
;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
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Manufacturer Reason
for Recall |
Due to manufacturing issue, panels may result in false negative results.
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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.
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| Quantity in Commerce |
705 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
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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.
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