CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Oxoid Microbact Identification Kits, Listeria Kit, 20 Tests recalled
Oxoid Australia is recalling Oxoid Microbact Identification Kits, Listeria Kit, 20 Tests, distributed nationwide in the US. The recall was initiated on 3 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1766-2026
- FDA event ID
- 98539
- Recalling firm
- Oxoid Australia, South Australia
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2026
- FDA classified
- 2 Apr 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Listeria
- Device type
- Other Medical Devices
Timeline
| 3 Mar 2026 | Recall initiated by company | |
| 2 Apr 2026 | Classified by FDA | +30 days |
| 8 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.
Product as listed by the FDA
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Where it was distributed
US Nationwide distribution in the states of GA and CA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 5032384127498, Lot Number 4494873
Where was it sold?
US Nationwide distribution in the states of GA and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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