Oxoid Agglutinating Sera, Salmonella 9-0 recallZ-1923-2026 · Remel Europe Ltd. · initiated Mar 25, 2026
Class II Open, Classified All recalls posted in April 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel Europe Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Firm began notifying consignees on March 25, 2026 via letters titled "Urgent: Medical Device Recall." Laboratory professionals are advised to review results and destroy any remaining inventory of affected lots. Affected lots should not be used for any clinical laboratory testing. Customers should complete and return the included acknowledgement form for replacement/credit to be processed. Notice should be passed on to all who need to be aware. Firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
Recall details
- Recall number
- Z-1923-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2026
- Posted by the FDA
- Apr 22, 2026
- Recalling firm
- Remel Europe Ltd.
- Quantity
- 117 US; 950 OUS
- Product code
- GRM
- Distribution
- Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Product description
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Code information (models, lots, serial numbers)
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA R30957301Remel Europe Limited · Antisera, All Groups, Salmonella Spp.1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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