Thermo Fisher Diagnostics Neisseria meningitidis Gp C… recallZ-2927-2026 · Remel Europe Ltd. · initiated Jul 17, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel Europe Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
FDA root cause category: Under Investigation by firm
What the company is doing
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 the completed form indicating number of units destroyed via email to [email protected] in order for your replacement/credit to be processed. Complete and return the response form even if you no longer have the affected product on hand. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]."
Recall details
- Recall number
- Z-2927-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 17, 2026
- Posted by the FDA
- Aug 7, 2026
- Recalling firm
- Remel Europe Ltd.
- Quantity
- 26 units
- Product code
- GTJ
- Distribution
- US Nationwide distribution.
Product description
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Code information (models, lots, serial numbers)
UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA R30166901Remel Europe Limited · Antisera, All Groups, N. Meningitidis1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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