FDA recall Z-1356-2019

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.

Reason for recall

Devices were delivered without the required dry ice.

Distribution

Distribution to Latvia.

Key facts

Status

Terminated

Initiation date

2019-04-09

Report date

2019-05-22

Termination date

2019-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2019