Home/Recalls/FDA-Z-2927-2026
FDA DevicesClass II

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

Published: August 19, 2026Recall ID: Z-2927-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: Remel Europe Ltd.

Reason for Recall / Hazard

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

Product Description & Identification

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

Additional Source Details

FieldValue
CityDartford
Event id99450
Address 1Clipper Boulevard West
Address 2Ken
Code infoUDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
Postal codeN/A
Report date20260819
Product typeDevices
Product quantity26 units
Reason for recallCertain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260717
Initial firm notificationLetter
Center classification date20260807

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Overview

  • Recalling FirmRemel Europe Ltd.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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