CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Multiple-type respiratory pathogen nucleic acid IVD, kit recalled
BioFire Diagnostics is recalling Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT), distributed nationwide in the US. The recall was initiated on 12 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0149-2027
- FDA event ID
- 99592
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2026
- FDA classified
- 13 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 12 Aug 2026 | Recall initiated by company | |
| 13 Oct 2026 | Classified by FDA | +62 days |
| 21 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99592This product is part of a recall event; the main page for the event is Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
More recalls from BioFire Diagnostics
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | Biofire Spotfire Respiratory/Sore Throat Panel recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
Other CPAP & Ventilators recalls
All 556| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |