FDA Device recall Z-0977-2013
BS-200 Chemistry Analyzer Designed for clinical laboratory use
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of BS-200 Chemistry Analyzer Designed for clinical laboratory use by Mindray Ds Usa D B A Mindray North America, citing an issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0977-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-28 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa D B A Mindray North America |
| Distribution | NC, TX |
Product
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Reason
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Identifiers
| code_info | Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2013%22
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