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Oxoid Australia Pty Limited: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Medical DevicesSource: FDA (device) · Date: 2026-04-08

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Oxoid Australia Pty Limited
Product
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of GA and CA.
Recall initiated
2026-03-03
Code info
UDI/DI 5032384127498, Lot Number 4494873
Product quantity
2 kits
Voluntary mandated
Voluntary: Firm initiated
City
South Australia
Country
Australia
Event id
98539
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