Recall Z-2478-2019— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-2478-2019
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: K160571. Product: cobas c513 Analyzer. 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

K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (Rdo)·cleared 2016-12-19

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 c513 Analyzer

Reason for recall

Quality issue with high pressure solenoid valves

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