FDA-Device2013-04-03Class II

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Mindray DS USA, Inc. d.b.a. Mindray North America
Hazard

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

Sold states
Distributed in the states of NC and TX.
Affected count
3 units
Manufactured in
800 MacArthur Blvd., Mahwah, NJ, United States
Products
BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2013

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