FilmArray Pneumonia Panel (Pneumo) recallZ-1944-2021 · BioFire Diagnostics, LLC · initiated Apr 16, 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
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
FDA root cause category: Under Investigation by firm
What the company is doing
On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 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) Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. 4) If the affected products have been further distributed, customers are to identify any recipients and notify them at once of this product recall. 5) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to Recalling Firm so that it may acknowledge their receipt of this notification. For questions or concerns contact Customer Support Department at [email protected] or via telephone 1-800-735-6544, option 5 for Product Technical Support.
Recall details
- Recall number
- Z-1944-2021
- Status
- Terminated
- Initiated by the company
- Apr 16, 2021
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 9 kits (U.S. only)
- Product code
- QBH
- FDA submissions
- K180966
- Distribution
- U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Product description
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Code information (models, lots, serial numbers)
Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0144Biofire Diagnostics, LLC · Respiratory Panel5 recalls7 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K180966 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0145Biofire Diagnostics, LLC · Respiratory Panel2 recalls0 reports
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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