Z-0977-2013 Class II Terminated
FDA device recall Z-0977-2013 was initiated by Mindray DS USA, Inc. d.b.a. Mindray North America on November 28, 2012 and is designated Class II. Reason for recall: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. The recall status is terminated (terminated June 12, 2013). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2013
- Initiation Date
- November 28, 2012
- Termination Date
- June 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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.
Distribution Pattern
Distributed in the states of NC and TX.
Code Information
Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.