Z-1355-2019 Class III Terminated
FDA device recall Z-1355-2019 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
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Reason for Recall
Devices were delivered without the required dry ice.
Distribution Pattern
Distribution to Latvia.
Code Information
LN 1L76-01; Lot 46K15718