FDA recall, , Moderate risk
Oxoid Agglutinating Sera, Salmonella 9-0
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 may cross-react with 2-0 within 60 seconds, potentially causing misidentification of Salmonella serotypes.
Summary by Recall Canary from the FDA notice
What happened
Remel Europe Ltd. of Dartford, United Kingdom, voluntarily recalled Oxoid Agglutinating Sera, Salmonella 9-0 R30957301, because affected lots are not performing to IFU criteria, showing cross reactions with 2-0 within 60 seconds. The cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype. The company began the recall on March 25, 2026, and it was added to the FDA's Enforcement Report and classified on April 22, 2026.
The product was distributed worldwide, with US Nationwide distribution to Alabama, California, Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Ohio, South Dakota, Texas, and Washington. Customers were notified by letter. The recall involved 117 US and 950 OUS units.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- UDI-DI
- 05056080500270
- Lot code
- 6172600
- 6172741
- 6171393
- 6150168
- 6107767
- 3766399
- 3766400
- 3780497
- 3719592
- 3709358
- 6266130
- 6253410
- 6260215
- 6222350
- 6233859
- 6233858
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Apr 20, 2026
- Sold in
Worldwide - US Nationwide distribution to the states of Alabama, California, Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Ohio, South Dakota, Texas, Washington.
- Recalled by
- Remel Europe Ltd.Dartford, United Kingdom
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98652
- Recall number
- Z-1923-2026
- Quantity recalled
- 117 US; 950 OUS
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Remel Europe Ltd.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Remel Europe began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
