CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 recalled
Remel Europe is recalling Oxoid Agglutinating Sera, Salmonella 9-0 R30957301, distributed nationwide in the US. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1923-2026
- FDA event ID
- 98652
- Recalling firm
- Remel Europe, Dartford, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Salmonella
- Device type
- Other Medical Devices
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +28 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Salmonella causes fever, diarrhea and abdominal cramps, usually 12 to 72 hours after eating contaminated food. Most people recover without treatment, but severe cases can need hospital care.
Product as listed by the FDA
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Where it was distributed
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Nationwide AlabamaCaliforniaFloridaIowaIllinoisIndianaMichiganMinnesotaMissouriNorth CarolinaNebraskaOhioSouth DakotaTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Where was it sold?
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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