Oxoid Australia Pty Limited recalls OXOID MICROBACT IDENTIFICATION KITS

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.

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

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 MBD.vigilance@thermofisher.com 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 microbiology.ts.us@thermofisher.com.

• FDA enforcement recordOfficial FDA database entry for Z-1766-2026
• FDA device classification · LQLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Oxoid Australia Pty LimitedSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.