Recall Z-1269-2018— Roche Diagnostics Corporation

Name: FDA recall Z-1269-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-18

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-12-18, terminated 2019-04-09. It names one FDA 510(k) clearance: K953239. Product: Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.. Reason: Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Terminated: 2019-04-09
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K953239 — BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERBoehringer Mannheim Corp.·cleared 1995-09-25

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

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.

Reason for recall

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

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