Device product
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Z-1357-2019
Product summary
- Event
- Event 82590
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1357-2019
Official wording
Reason: Devices were delivered without the required dry ice.
Code information: LN 8K25-12; Lot 01018I000
Distribution pattern: Distribution to Latvia.
Derived failure modes
-
Unknown
Devices were delivered without the required dry ice.