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Terminated

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

FDA Recall Z-0977-2013 · Posted 2013-03-22

Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
Recall StatusTerminated
Product CodeCFR
Date Initiated2012-11-28
Date Terminated2013-06-12
Product Quantity3 units

Reason for Recall

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

Firm Action

Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.

Root Cause

Device Design

Distribution Pattern

Distributed in the states of NC and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008-02-01K022519LDL CHOLESTEROL (AUTOMATED)Jas Diagnostics, Inc. · 2002-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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