FDA Device recall Z-3122-2024

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

FDA Device
Class II
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class II recall of FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W by Biofire Diagnostics, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3122-2024
Classification	Class II
Status	ongoing
Initiated	2024-08-07
Published	2024-09-18
Last updated	2026-09-13 11:57 UTC
Company	Biofire Diagnostics
Distribution	US

Product

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Reason

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.

Identifiers

code_info	FLM2-ASY-0001, UDI: 00815381020031, Serial Numbers: 2FA00610, 2FA00951, 2FA00964, 2FA01005, 2FA01115, 2FA01116, 2FA0112… 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, 2FA00386, 2FA00396, 2FA00551, 2FA00558, 2FA01693, 2FA02188, 2FA02296, 2FA02347, 2FA02422, 2FA05086, 2FA05089, 2FA05099, 2FA05172, 2FA05186, 2FA05256, 2FA05273, 2FA05287, 2FA05300, 2FA05601, 2FA06055, 2FA06140, 2FA06236, 2FA06297, 2FA06655, 2FA06867, 2FA07093, 2FA07173, 2FA07175, 2FA07194, 2FA07260, 2FA07312, 2FA07728, 2FA07848, 2FA07849, 2FA07856, 2FA07859, 2FA07860, 2FA07867, 2FA07870, 2FA07892, 2FA07916, 2FA07933, 2FA07976, 2FA07978, 2FA08054, 2FA08145, 2FA08336, 2FA08559, 2FA08579, 2FA08700, 2FA08728, 2FA08785, 2FA09867, FA2461, FA2464, FA2893, FA3170, FA3566, 2FA09893, 2FA00673, 2FA00983, 2FA01178, 2FA01250, 2FA02300

code_info

FLM2-ASY-0001, UDI: 00815381020031, Serial Numbers: 2FA00610, 2FA00951, 2FA00964, 2FA01005, 2FA01115, 2FA01116, 2FA0112…

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, 2FA00386, 2FA00396, 2FA00551, 2FA00558, 2FA01693, 2FA02188, 2FA02296, 2FA02347, 2FA02422, 2FA05086, 2FA05089, 2FA05099, 2FA05172, 2FA05186, 2FA05256, 2FA05273, 2FA05287, 2FA05300, 2FA05601, 2FA06055, 2FA06140, 2FA06236, 2FA06297, 2FA06655, 2FA06867, 2FA07093, 2FA07173, 2FA07175, 2FA07194, 2FA07260, 2FA07312, 2FA07728, 2FA07848, 2FA07849, 2FA07856, 2FA07859, 2FA07860, 2FA07867, 2FA07870, 2FA07892, 2FA07916, 2FA07933, 2FA07976, 2FA07978, 2FA08054, 2FA08145, 2FA08336, 2FA08559, 2FA08579, 2FA08700, 2FA08728, 2FA08785, 2FA09867, FA2461, FA2464, FA2893, FA3170, FA3566, 2FA09893, 2FA00673, 2FA00983, 2FA01178, 2FA01250, 2FA02300

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3122-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.