CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Thermo Fisher Diagnostics Neisseria meningitidis Gp C/VL recalled
Remel Europe is recalling Thermo Fisher Diagnostics Neisseria meningitidis Gp C/VL, Product Number R30166901, distributed nationwide in the US. The recall was initiated on 17 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2927-2026
- FDA event ID
- 99450
- Recalling firm
- Remel Europe, Dartford
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jul 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +21 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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