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U.S. Department of Health and Human Services

Class 2 Device Recall OXOID MICROBACT LISTERIA IDENTIFICATION KITS

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 Class 2 Device Recall OXOID MICROBACT LISTERIA IDENTIFICATION KITSsee related information
Date Initiated by FirmMarch 03, 2026
Date PostedApril 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1766-2026
Recall Event ID 98539
Product Classification Gram positive identification panel - Product Code LQL
ProductOXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Code Information UDI/DI 5032384127498, Lot Number 4494873
FEI Number 3006440892
Recalling Firm/
Manufacturer		 Oxoid Australia Pty Limited
20 Dlgleish St
South Australia Australia
For Additional Information ContactErica Knox
800-255-6730
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThermo 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.
Quantity in Commerce2 kits
DistributionUS Nationwide distribution in the states of GA and CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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