| | Class 2 Device Recall Oxoid Agglutinating Sera, Salmonella 90 |  |
| Date Initiated by Firm | March 25, 2026 |
|---|
| Date Posted | April 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1923-2026 |
|---|
| Recall Event ID |
98652 |
| Product Classification |
Antisera, all groups, salmonella spp. - Product Code GRM
|
| Product | Oxoid Agglutinating Sera, Salmonella 9-0
R30957301 |
|---|
| Code Information |
UDI-DI 05056080500270
lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858 |
| FEI Number |
3003750284
|
Recalling Firm/
Manufacturer |
Remel Europe Ltd.
Clipper Boulevard West
Ken
Dartford United Kingdom
|
| For Additional Information Contact | Erica Knox
800-2556730 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
