Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

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 MBD.vigilance@thermofisher.com 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 microbiology.ts.us@thermofisher.com."

• FDA enforcement recordOfficial FDA database entry for Z-2927-2026
• FDA device classification · GTJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3390The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Remel Europe Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.