Device product
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Z-0073-2013
Product summary
- Event
- Event 62516
- Status
- Terminated
- Classification
- Class III
- Quantity
- 127 sites
- Official record key
device-enforcement:Z-0073-2013
Official wording
Reason: Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Code information: Versions 6.4.0 and later
Distribution pattern: Nationwide distribution
Derived failure modes
-
Unknown
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.