FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. d.b.a. Mindray North America: BS-200 Chemistry Analyzer Designed for clinical laboratory use.
- Recall number
- Z-0977-2013
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Product
- BS-200 Chemistry Analyzer Designed for clinical laboratory use.
- Status
- Terminated
- Initiated
- 2012-11-28
- Posted
- 2013-03-22
- Terminated
- 2013-06-12
- Reason
- An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 3 units
- Distribution
- Distributed in the states of NC and TX.
- Lot, serial or model codes
- Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
- 510(k) numbers
- ["K022519","K072018"]
- PMA numbers
- not on file
- Product code
- CFR
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28