Class II — Mindray DS USA, Inc. d.b.a. Mindray North America
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Registered facility | MINDRAY DS USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. |
| Product | BS-200 Chemistry Analyzer Designed for clinical laboratory use. |
| Quantity | 3 units |
| Distribution | Distributed in the states of NC and TX. |
| Initiated | 2012-11-28 |
| Classified | 2013-03-22 |
| Terminated | 2013-06-12 |
| Recall number | Z-0977-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mindray DS USA, Inc. d.b.a. Mindray North America (Z-0977-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64112/
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