Z-2439-2023Class II

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

Name: Z-2439-2023 BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Creator: BioFire Diagnostics, LLC
Published: 2023-05-08
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-05-08 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only on 2023-05-08. FDA classified it as Class II and gives the reason as "Due to manufacturing issue, panels may result in false negative results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2439-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-08
Posted: 2023-08-21
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: Due to manufacturing issue, panels may result in false negative results.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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.
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2439-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2439-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-21
Z-2440-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-21

Product code QOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)