Recall Z-0099-2017— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0099-2017
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: K012397. Product: URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.. 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

K012397 — URISYS 2400 URINE TEST STRIPRoche Diagnostics Corp.·cleared 2001-09-26

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

URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.

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.