Recall Z-0096-2017— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0096-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-15

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2016-07-15, terminated 2017-06-05. It names one FDA 510(k) clearance: K060373. Product: cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.. Reason: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Terminated: 2017-06-05
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 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.

Reason for recall

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

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