BS-200 Chemistry Analyzer Designed for clinical laboratory use — Class II medical device recall Z-0977-2013
Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2013-04-03, distributed in NC, TX. An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
| Recall number | Z-0977-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2013-03-22 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-06-12 |
| Distributed | NC, TX |
| Quantity | 3 units |
| Serial numbers | WN-28103976F, WN-28103977F, WN-28103978F |
| Model numbers | BA20E-PA00003 |
Product
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Reason for recall
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0977-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.