Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

FDA device recall Z-1923-2026 · posted 2026-04-22 · Open, Classified

Recall details

Recalling firm

Remel Europe Ltd.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GRM

Quantity affected

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.

Date initiated

2026-03-25

Date posted

2026-04-22

Location

West Ken Dartford, United Kingdom