BS-200 Chemistry Analyzer Designed for clinical laboratory use.
FDA device recall Z-0977-2013 · posted 2013-03-22 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
- Action taken
- Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CFR
- Quantity affected
- 3 units
- Distribution
- Distributed in the states of NC and TX.
- Date initiated
- 2012-11-28
- Date posted
- 2013-03-22
- Date terminated
- 2013-06-12
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BS-200 CHEMISTRY ANALYZER, MODE BS-200 (K072018) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-02-01 |
| LDL CHOLESTEROL (AUTOMATED) (K022519) | Jas Diagnostics, Inc. | 2002-09-30 |