FDAClass IIApril 3, 2013

BS-200 Chemistry Analyzer Designed for clinical recall

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Why was BS-200 Chemistry Analyzer Designed for clinical recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Recalling firm
Mindray DS USA, Inc. d.b.a. Mindray North America
Quantity
3 units
Distribution
Distributed in the states of NC and TX.
Recall date
April 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls