Class II
Medical Device Recall: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Remel Europe Ltd. · July 17, 2026
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
26 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2927-2026
Status: ongoing
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