Recall Z-2477-2019— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-2477-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-18

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-07-18, terminated 2020-06-15. It names one FDA 510(k) clearance: K100853. Product: Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001. Reason: Quality issue with high pressure solenoid valves.

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-18
Terminated: 2020-06-15
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K100853 — COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.·cleared 2010-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

Reason for recall

Quality issue with high pressure solenoid valves

Data sourced from openFDA. This site is unofficial and independent of the FDA.