{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "209116", "product_res_number": "Z-3122-2024", "event_date_initiated": "2024-08-07", "event_date_posted": "2024-09-11", "recall_status": "Open, Classified", "res_event_number": "95019", "product_code": "NSU", "k_numbers": [ "K143178" ], "product_description": "FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W", "code_info": "FLM2-ASY-0001, UDI: 00815381020031, Serial Numbers: 2FA00610, 2FA00951, 2FA00964, 2FA01005, 2FA01115, 2FA01116, 2FA01128, 2FA01418, 2FA01653, 2FA01733, 2FA01771, 2FA01775, 2FA01878, 2FA02805, 2FA02977, 2FA02981, 2FA03194, 2FA03196, 2FA03237, 2FA03273, 2FA03303, 2FA03335, 2FA03343, 2FA06079, 2FA06473, 2FA07884, 2FA07987, 2FA07996, 2FA08386, 2FA01224, 2FAD848B, 2FA00229, 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2FA09154, 2FA09277, 2FA09290, 2FA09936, 2FA10137, 2FA26D4C, 2FA39CFB, 2FA3E685, 2FA46A79, 2FA49D78, 2FA4D8D7, 2FA5A2EF, 2FA72E4F, 2FA74CFA, 2FA770A3, 2FAA0968, 2FAD9D4B, 2FADA123, 2FAF0FAE, FA2131, 2FA01877, 2FA07144, 2FA01541, 2FA06672, 2FA08150, 2FA01179, 2FA03219, 2FA491E9, 2FA12FC8, FA3684, 2FA06598, 2FA02698, 2FA03025, 2FA05209, 2FA05633, 2FA06072, 2FA06496, 2FA06732, 2FA07256, 2FA07992, FA2680, FA3000, FA3303, 2FA02872", "firm_fei_number": "3002773840", "recalling_firm": "BioFire Diagnostics, LLC", "address_1": "515 S Colorow Dr", "city": "Salt Lake City", "state": "UT", "postal_code": "84108-1248", "additional_info_contact": "Customer Support Department\n800-736-6354", "reason_for_recall": "Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.", "root_cause_description": "Under Investigation by firm", "action": "On 8/7/24 Biomerieux sent recall notices to customers who were asked to do the following: \n\n1) Utilize http://biofiredx.com/fsca5788-1/ to determine which of your instruments are impacted. \n2) If your instrument is on the impacted list, it needs to be returned to the firm's Service Center for recalibration; your local contact will reach out to you to coordinate instrument return.\n3) Continue to use all your instruments in accordance with product labeling (instructions for use) while waiting for service.\n4) For BIOFIRE GI Panel Users, you may continue using the product as directed in the package insert, but if a positive Salmonella or Giardia lamblia result is inconsistent with clinical presentation, consider confirming the positive using another method or rerun the sample on an unaffected instrument. In patients suspected of Norovirus infection, please consider confirming Norovirus results via another method prior to reporting those results or rerun the sample on an unaffected instrument.\n5) For BCID2 users, you may continue using the product as directed in the package insert; however, in patients with a Staphylococcus aureus detected result on the BCID2 panel AND suspected of a MRSA infection, please confirm all negative MRSA results via another method prior to reporting or rerun the sample on an unaffected instrument.\n6) For RP2.1, RP2.1plus, ME, PN, PNplus and JI users, you may continue using the product as directed in the package insert; No confirmation of results are required.\n7) If you have further distributed impacted instrument(s), identify any recipients and notify them at once by sending them a copy of the recall notice and acknowledgement form.\n8) Complete all fields of the accompanying Acknowledgment of Receipt Form via email and return to USfieldactions@biomerieux.com or the form can be filled out electronically by following URL: https://www.biofiredx.com/recall5788-1/ \n\nCustomers with questions can contact Technical Support at biofiresupport@biomer", "product_quantity": "1001", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.", "openfda": { "k_number": [ "K143178", "K133849", "K073506", "K093128", "K110786", "K082562", "DEN040012", "K070597", "K121399", "K133302", "K141220", "K163652", "K080995" ], "registration_number": [ "9610126", "2183715", "3003423869", "3003795116", "3012259842", "3016531205", "3007799234", "9615056", "3008494306", "3010770794", "2243471", "3004141078", "3038610665", "3008632402", "3003314809", "3002777243", "2915274", "3017907743", "1650733", "3017019647", "3003673482", "3013019728", "3010461097", "3009189893", "3017358793", "1628664", "3035381641", "3042641161", "3004530258", "3007361513", "3016611336", "3004105270", "3016838963", "3002773840", "3005967741", "8043379", "2032682", "3016068451", "3005370583", "3007886270", "3003366417", "3005406097", "3012348571", "3014515702", "3007118747", "2024800", "3016733849", "3006198300", "3007420875", "3013540184", "3021389305", "1119779", "3014325803", "3007719797", "3014214006", "2026994", "8020030", "3006028115", "3010286073", "3007143373", "3005269352", "3032023483", "3007208259" ], "fei_number": [ "2183715", "3003423869", "3003795116", "3012259842", "3016531205", "3007799234", "1000186023", "3008494306", "3010770794", "2243471", "3004141078", "3008272466", "3008632402", "3038610665", "3003413192", "3003314809", "3002777243", "3017907743", "2915274", "3002524000", "3017019647", "3003952975", "3003673482", "3013019728", "3010461097", "3009189893", "3017358793", "1628664", "3035381641", "3042641161", "3004530258", "3007361513", "3016611336", "3004105270", "3016838963", "3002773840", "3005967741", "3006461677", "3016068451", "3005370583", "3005406097", "3003366417", "3012348571", "3014515702", "3002806559", "3007118747", "2024800", "3016733849", "3006198300", "3007420875", "3013540184", "3021389305", "1119779", "3014325803", "3007719797", "3014214006", "2026994", "3006028115", "3010286073", "3007143373", "3005269352", "3032023483", "3007208259" ], "device_name": "Instrumentation For Clinical Multiplex Test Systems", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2570", "device_class": "2" } } ] }