United StatesWhat's being recalled
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
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
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Recalling firm: BioFire Diagnostics, LLC, Salt Lake City, UT, United States.
How to identify it
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 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 Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit); Lot Numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, 1684726
The hazard
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was 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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)