Z-1923-2026Class II

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Name: Z-1923-2026 Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Creator: Remel Europe Ltd.
Published: 2026-03-25
License: https://open.fda.gov/license/

Remel Europe Ltd. / initiated 2026-03-25 / Open, Classified / root cause: labeling and UDI

FDA source

Remel Europe Ltd. began a recall of Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 on 2026-03-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1923-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-04-22
Recalling firm: Remel Europe Ltd.
Product: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Product code: GRM Antisera, All Groups, Salmonella Spp.
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 117 US; 950 OUS
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 codes and lots: UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1923-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1923-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code GRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)