Recall Z-0977-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0977-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2012-11-28, terminated 2013-06-12. It names 2 FDA 510(k) clearances: K072018, K022519. Product: BS-200 Chemistry Analyzer Designed for clinical laboratory use.. Reason: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Terminated: 2013-06-12
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K072018 — BS-200 CHEMISTRY ANALYZER, MODE BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2008-02-01
K022519 — LDL CHOLESTEROL (AUTOMATED)Jas Diagnostics, Inc.·cleared 2002-09-30

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

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Reason for recall

An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

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