Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144
Summary
The FDA issued a Class II for Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Pan by BioFire Diagnostics, LLC. Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results.
Details
Source
Device Recall
External ID
Z-0148-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Lot/Code Info: Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); Lot Numbers 0638726, 0676626, 0676726, 0716526, 0727826, 0767926, 0804526, 0804626, 0860926, 0882826, 0882926, 0883026, 0914626, 0914726, 0914826, 0914926, 0969126, 0969726, 0978026, 0978126, 0978226, 0978326, 0997626, 0997826, VK0997826, 0999226, 1020826, 1020926, 1105426, 1119126, 1119226, 1119326, 1119426, 1151826, 1152326, 1152426, 1179726, 1219026, 1267526, 1286226, 1286326, 1286426, 1346126, 1402726, 1402826, 1402926, 1419126, 1419226, 1437526, 1478926, 1560326, 1560426, 1560526, 1630726, 1656826, 1683726, 1702326, 1708826
Quantity Affected: 4,892
Reason for Recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-12
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 31 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioFire Diagnostics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioFire Diagnostics, LLC have FDA actions?
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 31 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0148-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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