FDA Device recall Z-1923-2026
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 by Remel Europe, citing affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1923-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Remel Europe |
| Distribution | US |
Product
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Reason
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Identifiers
| code_info | UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 62…UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1923-2026%22
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