Recall Z-2927-2026— Remel Europe Ltd.

Name: FDA recall Z-2927-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-17

Class II · Ongoing

Class II FDA medical device recall by Remel Europe Ltd., initiated 2026-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics. Reason: Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds..

Recalling firm: Remel Europe Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-17
Firm location: Dartford, United Kingdom

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.