FDA Medical Device Recalls (openFDA)
Oxoid Australia Pty Limited: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
- Recall number
- Z-1766-2026
- Recalling firm
- Oxoid Australia Pty Limited
- Product
- OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
- Status
- Open, Classified
- Initiated
- 2026-03-03
- Posted
- 2026-04-02
- Terminated
- not on file
- Reason
- 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.
- 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 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
- 2 kits
- Distribution
- US Nationwide distribution in the states of GA and CA.
- Lot, serial or model codes
- UDI/DI 5032384127498, Lot Number 4494873
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LQL
- Firm FEI
- 3006440892
- Firm city
- not on file
- Firm state
- South Australia
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28