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.
Reported: May 22, 2019 Initiated: April 9, 2019 #Z-1356-2019
Product Description
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.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 1 unit
- Distribution
- Distribution to Latvia.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: 1 unit.
Why was this product recalled? ▼
Devices were delivered without the required dry ice.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Low. Recall number: Z-1356-2019.
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