Device evidence

device-recall:cfres:171953

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.

Official recall number

Z-1356-2019

Evidence summary

Product code: JIT
Recall status: Terminated
Event initiated: April 09, 2019
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1356-2019