FDA-Device2026-04-08Class IIPROCESSING DEFECT
Oxoid Microbact 12L Listeria identification kit recalled for incorrect organism identification
Nationwide distributionMedical devices
What this means
Oxoid's Microbact 12L Kit (lot 4494873) may produce ambiguous color reactions in test wells that could lead to incorrect organism identification. This affects a limited number of kits distributed in Georgia and California.
- Do not use Microbact 12L Kit lot 4494873 (MB1128A, UDI 5032384127498) for organism identification
- Contact Oxoid or your supplier for instructions on returning or replacing affected kits
- Contact the FDA if you have used this kit and identified an organism
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
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-1766-2026Want us to check the next one for you?
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