Recall Z-1361-2019— Abbott Laboratories
Class III · Terminated
Class III FDA medical device recall by Abbott Laboratories, initiated 2019-04-09, terminated 2019-12-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Devices were delivered without the required dry ice..
- Recalling firm
- Abbott Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-09
- Terminated
- 2019-12-20
- Firm location
- Abbott Park, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.