Z-1944-2021Class II

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Name: Z-1944-2021 FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Creator: BioFire Diagnostics, LLC
Published: 2021-04-16
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-04-16 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 on 2021-04-16. FDA classified it as Class II and gives the reason as "Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1944-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2021-06-24
Terminated: 2024-04-02
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Product code: QBH Lower Respiratory Microbial Nucleic Acid Detection System
Reason for recall: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 9 kits (U.S. only)
Distribution: U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Product codes and lots: Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24

Product code QBH

K180966Class IIFilmArray Pneumonia PanelBiofire Diagnostics, LLC / cleared 2018-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)