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.
Other recalls by Mindray Ds Usa D B A Mindray North America
- Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack
FDA Device · Class II · 2013-02-20 · Mindray Ds Usa D B A Mindray North America - Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities
FDA Device · Class II · 2013-02-06 · Mindray Ds Usa D B A Mindray North America - DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers i…
FDA Device · Class II · 2013-01-09 · Mindray Ds Usa D B A Mindray North America - Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W…
FDA Device · Class II · 2012-12-26 · Mindray Ds Usa D B A Mindray North America - DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd
FDA Device · Class II · 2012-12-19 · Mindray Ds Usa D B A Mindray North America
All Mindray Ds Usa D B A Mindray North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.