Open, Classified

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

FDA Recall Z-1923-2026 · Posted 2026-04-22

Recall StatusOpen, Classified

Product CodeGRM

Date Initiated2026-03-25

Product Quantity117 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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.