Official recall notice

FDA DeviceClass IINotable

Thermo Fisher Diagnostics Neisseria Recall (Aug 2026)

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

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

Hazard

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

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

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

Affected products

UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.

Verify with the official notice →
Share:

Related Recalls

2026-10-06 · FDA_DEVICE
FDA Recall: Nova Biomedical StatStrip: StatStrip Glucose Hospital Meter System
Nova Biomedical StatStrip
2026-09-30 · FDA_DEVICE
FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod
Abiomed, Inc.
2026-09-30 · FDA_DEVICE
FDA Recall: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3.
INTERVASCULAR, SAS
2026-09-30 · FDA_DEVICE
FDA Recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Olympus Corporation of the Americas