Z-2040-2021Class II

FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30...

Name: Z-2040-2021 FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30...
Creator: BioFire Diagnostics, LLC
Published: 2021-06-07
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-06-07 / Terminated

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI... on 2021-06-07. FDA classified it as Class II and gives the reason as "Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2040-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-07
Posted: 2021-07-08
Terminated: 2023-07-31
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Product code: QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Reason for recall: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
FDA root cause: Under Investigation by firm
Action: On 06/03/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via overnight FedEx informing its customer that it has identified a potential for obtaining elevated rates of negative adenovirus results when using the pneumonia panel. The potential false negative results are due to a 10-100x reduction in sensitivity specifically for adenovirus species C when using the pneumonia panel kits within 6 months of expiration. In addition: -The test performance is NOT impacted if kits are more than 6 months from expiration date. -Performance for other adenovirus species (e.g. A, B, D, E, F, and G) are NOT affected -The adenovirus assays on all other of the Recalling Firm's Respiratory Panels are NOT affected. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. -If the customer identifies any affected Pneumonia Panels in their inventory (i.e. Pneumonia Panels within 6 months of shelf-life), they may continue using the affected product; however, when adenovirus C infection is suspected, negative results for Adenovirus should be confirmed by another method prior to reporting test results to clinicians, or alternatively, the Recalling Firm's Pneumonia Panel Adenovirus negative results should not be reported. 2) If a customer has further distributed this product, they are to identify their customers and notify them at once of this product recall. 3) Complete the enclosed Acknowledgement of Receipt Form as soon as possible and return it to the Recalling Firm via one of the methods listed on the Acknowledgement of Receipt Form - 1) Fill out electronically using the following URL: (https://www.biofiredx.com/pn-5183/) 2) Scan to PDF and return completed form to: [email protected] Any questions or assistance - contact customer support department at [email protected] or via telephone 1-800-735-6544 option 5.
Quantity in commerce: 3,559 kits (Globally)
Distribution: U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.
Product codes and lots: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2040-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2040-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08

Product code QDS

K181324Class IIFilmArray Pneumonia Panel plusBiofire Diagnostics, LLC / cleared 2018-11-15

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)