Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL
See all recalls from Remel Europe Ltd. →Recalled Product
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Hazard / Issue
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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