ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Reported: May 22, 2019 Initiated: April 9, 2019 #Z-1361-2019
Product Description
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
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? ▼
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.. 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-1361-2019.
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