FDA recall, , Moderate risk
Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests
Neisseria meningitidis Gp C 2ml/VL is not performing to IFU criteria, not positive to ATCC13102 within 60 seconds.
Summary by Recall Canary from the FDA notice
What happened
Remel Europe Ltd., based in Dartford, United Kingdom, began a recall on July 17, 2026, of Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901, an invitro diagnostics. The agency stated that certain lots are not performing to IFU criteria, not positive to ATCC13102 within 60 seconds. The recall involves 26 units and was added to the FDA's Enforcement Report on August 7, 2026, with distribution nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- UDI-DI
- 05056080501161
- Lot code
- 6214791
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Remel Europe Ltd.Dartford, United Kingdom
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99450
- Recall number
- Z-2927-2026
- Quantity recalled
- 26 units
All recalls from Remel Europe Ltd.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
