FilmArray BCID Panel recallZ-2245-2021 · BioFire Diagnostics, LLC · initiated Jul 20, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
FDA root cause category: Process control
What the company is doing
On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at [email protected] or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.
Recall details
- Recall number
- Z-2245-2021
- Status
- Terminated
- Initiated by the company
- Jul 20, 2021
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 29 kits
- Product code
- PEN
- FDA submissions
- K181493
- Distribution
- U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
Product description
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Code information (models, lots, serial numbers)
Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® BCID Panel RFIT-ASY-0126Biofire Diagnostics, LLC · Real Time Nucleic Acid Amplification System2 recalls2 deaths4 reports
- FilmArray® BCID Panel RFIT-ASY-0127Biofire Diagnostics, LLC · Real Time Nucleic Acid Amplification System2 recalls1 death1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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