OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Summary
The FDA issued a Class II for OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identi by Oxoid Australia Pty Limited. Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to in.
Details
Source
Device Recall
External ID
Z-1766-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Lot/Code Info: UDI/DI 5032384127498, Lot Number 4494873
Quantity Affected: 2 kits
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.
Distribution
US Nationwide distribution in the states of GA and CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-03
Company
South Australia
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oxoid Australia Pty Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oxoid Australia Pty Limited have FDA actions?
This is the only FDA action we have on record for Oxoid Australia Pty Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1766-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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