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BS-200 Chemistry Analyzer Designed for clinical laboratory use.

FDA Recall #Z-0977-2013 — Class II — November 28, 2012

Recall #Z-0977-2013 Date: November 28, 2012 Classification: Class II Status: Terminated

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.

Recalling Firm

Mindray DS USA, Inc. d.b.a. Mindray North America — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 units

Distribution

Distributed in the states of NC and TX.

Code Information

Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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