Recall Z-2927-2026 ยท GTJ Antisera, All Groups, N. Meningitidis
Remel Europe Ltd.
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
| Date | Aug 7, 2026 (initiated Jul 17, 2026) |
| Status | Open, Classified |
| Reason | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. |
| Root cause | Under Investigation by firm |
| Action | Thermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 7/17/2026 via USPS, first class mail. The notice explained the issue, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY THE CUSTOMER: Our records indicate that you have received above products. Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of this issue. Laboratory professionals are advised to destroy any remaining inventory of lots listed above. Please complete the accompanying Acknowledgement form and return |
| Quantity | 26 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.