Oxoid Agglutinating Sera recall (Remel Europe Ltd.)
Medical deviceClass IIOngoing
Summary: Remel Europe Ltd. is recalling 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.
What is being recalled
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA. (states named: Alabama, California, Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Ohio, South Dakota, Texas, Washington)
How to tell if yours is affected
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1923-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | April 29, 2026 |
| Company | Remel Europe Ltd. |
| Company location | Dartford, N/A, United Kingdom |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 117 US; 950 OUS |
More recalls from Remel Europe Ltd. · all medical device recalls · recalls from March 2026