ARCHITECT Intact PTH Calibrators - 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.
Reported: May 22, 2019 Initiated: April 9, 2019 #Z-1358-2019
Product Description
ARCHITECT Intact PTH Calibrators - 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.
Reason for Recall
Devices were delivered without the required dry ice.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 2 units
- Distribution
- Distribution to Latvia.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT Intact PTH Calibrators - 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.. Recalled by Abbott Laboratories. Units affected: 2 units.
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-1358-2019.
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