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Bbi Solutions Oem Limited

Country not established FDA establishment FEI 3014684020

Devices
0
Registrations
FDA
FDA recalls
1

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3014684020
Address
Unit 2 Parkway, Crumlin Newport

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2016

    • 1 Jun 2016 Z-0314-2017 Class II Terminated A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision. Distribution: US distribution to CT and IN Submission number: K905643

This is an FDA establishment record without devices in deviCERTS.