Roche Diagnostics Hematology, Inc.

Medical device manufacturer in Westborough, MA.

1510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K171655cobas m 511 integrated hematology analyzerGKZ · Traditional 03/02/2018SE

Recalls

RecallProductInitiated
Z-2557-2018 Class IIcobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The…Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency… 05/07/2018Terminated