Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model...
FDA Device Recall #Z-0149-2027 - Class II, August 12, 2026
Recall Summary
| Recall Number | Z-0149-2027 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 12, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BioFire Diagnostics, LLC |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 3,871 |
Product Description
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Reason for Recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.
Lot / Code Information
Lot Code: UDI Nos 00815381020314 (30 Kit), 00815381020321 (6 Kit); Model Nos RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit); Lot Numbers 0638426, 0638526, 0676426, 0676526, 0679726, 0804826, 0804926, 0805026, 0883126, 0922126, 0941426, 0941526, 0997926, 0998026, 1020626, 1020726, 1077326, 1105326, 1118926, 1119026, 1119526, 1219226, 1239726, 1286526, 1286626, 1287326, 1287426, 1346226, 1346326, 1346426, 1403026, 1403126, 1403226, 1419326, 1419426, 1437626, 1479026, 1560626, 1560726, 1611826, 1611926, 1656926, 1683826, 1859726
Other Recalls from BioFire Diagnostics, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0150-2027 | Class II | Generic Name: BioFire¿ Joint Infection (JI) Pan... | Aug 12, 2026 |
| Z-0148-2027 | Class II | Generic Name: FilmArray¿ Pneumonia Panel Gener... | Aug 12, 2026 |
| Z-2936-2026 | Class II | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 42374... | Jun 24, 2026 |
| Z-2067-2026 | Class II | BioFire Joint Infection (JI) Panel REF: RFIT-A... | Apr 22, 2026 |
| Z-2081-2026 | Class II | Biofire Spotfire Respiratory/Sore Throat Panel ... | Apr 1, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.