FDA-Device2026-04-08Class II

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Oxoid Australia Pty Limited
Hazard
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Sold states
US Nationwide distribution in the states of GA and CA.
Affected count
2 kits
Manufactured in
20 Dlgleish St, South Australia, Australia
Products
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2026

Original summary

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. UDI/DI 5032384127498, Lot Number 4494873 Distribution: US Nationwide distribution in the states of GA and CA. Affected quantity: 2 kits

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