Summary
The FDA issued a Class II for Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 by Remel Europe Ltd.. Reason: Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentificat.
Details
Source
Device Recall
External ID
Z-1923-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Lot/Code Info: UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Quantity Affected: 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.
Distribution
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Dartford, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remel Europe Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel Europe Ltd. have FDA actions?
This is the only FDA action we have on record for Remel Europe Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1923-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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