Device product
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Z-0977-2013
Product summary
- Event
- Event 64112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0977-2013
Official wording
Reason: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Code information: Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
Distribution pattern: Distributed in the states of NC and TX.
Derived failure modes
-
Unknown
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.