Z-1361-2019 Class III Terminated
FDA device recall Z-1361-2019 was initiated by Abbott Laboratories on April 9, 2019 and is designated Class III. Reason for recall: Devices were delivered without the required dry ice. The recall status is terminated (terminated December 20, 2019). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 9, 2019
- Termination Date
- December 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
Distribution to Latvia.
Code Information
LN 09P3501; Lot 84347UN18