Recall Z-1766-2026 ยท LQL Gram Positive Identification Panel
Oxoid Australia Pty Limited
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
| Date | Apr 2, 2026 (initiated Mar 3, 2026) |
| Status | Open, Classified |
| 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 |
| Quantity | 2 kits |
| Distribution | US Nationwide distribution in the states of GA and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.