Recall Z-1766-2026— Oxoid Australia Pty Limited
Class II · Ongoing
Class II FDA medical device recall by Oxoid Australia Pty Limited, initiated 2026-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem. 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..
- Recalling firm
- Oxoid Australia Pty Limited
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-03
- Firm location
- South Australia, Australia
Product description
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.