Device product
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
Z-1356-2019
Product summary
- Event
- Event 82590
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1356-2019
Official wording
Reason: Devices were delivered without the required dry ice.
Code information: LN 4P72-01; Lot 902920500
Distribution pattern: Distribution to Latvia.
Derived failure modes
-
Unknown
Devices were delivered without the required dry ice.