FDAFDA · Food and drugs·Recall number Z-0977-2013
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Published April 3, 2013 · Recall initiated: November 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Distributor
- Distributed in the states of NC and TX.
- Lot
- Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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