Recall Z-1923-2026 ยท GRM Antisera, All Groups, Salmonella Spp.
Remel Europe Ltd.
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
| Date | Apr 22, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.