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Neisseria meningitidis Gp C 2ml/VL
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MEDICAL DEVICE RECALLMODERATE

Neisseria meningitidis Gp C 2ml/VL

Remel recalls Neisseria meningitidis Gp C 2ml/VL (R30166901) for failing to test positive within 60 seconds.

What to do

Do not use the affected product. Contact Remel Europe Ltd. for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2927-2026
Agency
FDA
Firm
Remel Europe Ltd.
Recall ID
99450
Status
ONGOING

Recall at a glance

Quantity recalled
26 units

Why it was recalled

Remel Europe Ltd. is recalling certain lots of Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901, an in vitro diagnostic reagent, because the product is not performing to IFU criteria and does not test positive to ATCC13102 within 60 seconds.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
6214791, 2025
UDI-DI
05056080501161

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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All recalls from Remel Europe Ltd.

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Editorial summary by Recall Canary · summary updated 2026-08-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification