Recall Z-0909-2018— Roche Diagnostics Corporation

Name: FDA recall Z-0909-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-18

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-07-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K060373. Product: cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V. Reason: A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-18
Terminated: 2018-07-13
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060373 — COBAS 6000 SERIES SYSTEMRoche Diagnostics·cleared 2006-03-13

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 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

Reason for recall

A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.

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