FDA DevicesClass II
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Published: April 29, 2026Recall ID: Z-1923-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Affected Products
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Additional Source Details
| Field | Value |
|---|---|
| City | Dartford |
| State | N/A |
| Event id | 98652 |
| Address 1 | Clipper Boulevard West |
| Address 2 | Ken |
| Code info | UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858 |
| Postal code | N/A |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 117 US; 950 OUS |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmRemel Europe Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.