Z-1766-2026Class II

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

Name: Z-1766-2026 OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Creator: Oxoid Australia Pty Limited
Published: 2026-03-03
License: https://open.fda.gov/license/

Oxoid Australia Pty Limited / initiated 2026-03-03 / Open, Classified

FDA source

Oxoid Australia Pty Limited began a recall of OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem on 2026-03-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1766-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-03
Posted: 2026-04-02
Recalling firm: Oxoid Australia Pty Limited
Product: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Product code: LQL Gram Positive Identification Panel
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.
FDA root cause: Under Investigation by firm
Action: Thermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 3/3/2036 via USPS First Class Mail. The notice explained problem, risk to health, requested the consignee destroy any remaining inventory of the affected lot and responding by completing the Acknowledgement form and returning it via email to [email protected] in order to receive replacement/credit to be processed keeping the notification on file. The notice further requests it be passed on to all who need to be aware within the consignee's organization or to any organization where the potentially affected products have been transferred. For questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected].
Quantity in commerce: 2 kits
Distribution: US Nationwide distribution in the states of GA and CA.
Product codes and lots: UDI/DI 5032384127498, Lot Number 4494873

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1766-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1766-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

Product code LQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)