FDA Medical devices recall ·
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 recall
- Recall number
- Z-1923-2026
- Date
- (initiated March 25, 2026)
- Company / brand
- Remel Europe Ltd.
Clipper Boulevard West, Dartford, N/A, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 117 US; 950 OUS
- Hazard tags
- Salmonella
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Distribution
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
States: Alabama California Florida Iowa Illinois Indiana Michigan Minnesota Missouri North Carolina Nebraska Ohio South Dakota Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1923-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.