Device product
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Z-1360-2019
Product summary
- Event
- Event 82590
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1360-2019
Official wording
Reason: Devices were delivered without the required dry ice.
Code information: LN 3P25-02; Lot 93284UIOO
Distribution pattern: Distribution to Latvia.
Derived failure modes
-
Unknown
Devices were delivered without the required dry ice.