Remel Neisseria meningitidis Gp C test recalled for poor performance
Certain lots of the Remel (Thermo Fisher Diagnostics) Neisseria meningitidis Group C 2 mL test, product R30166901, did not perform as its instructions require. The test did not return a positive result with a reference control strain within 60 seconds. About 26 units were distributed nationwide, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Remel recalls
What to do
- Check whether your lab has product R30166901 with lot 6214791, 6175327, 6148809, or 6002010.
- Stop using any affected lots and set them aside until you receive guidance from the manufacturer.
- Contact Remel or Thermo Fisher Diagnostics for next steps, since the notice does not list a specific remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 26 units
- Illnesses reported
- None reported
- Manufactured in
- Clipper Boulevard West, Ken, Dartford, United Kingdom
- Classification
- Class II
- Recall number
- Z-2927-2026
In the FDA's words
- Description
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. 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. Affected quantity: 26 units
- Hazard
- Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.