FDA Medical devices recall ·
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL… recall
- Recall number
- Z-2927-2026
- Date
- (initiated July 17, 2026)
- Company / brand
- Remel Europe Ltd.
Clipper Boulevard West, Dartford, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 26 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Why was it recalled?
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2927-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.