Z-1360-2019 Class III Terminated
FDA device recall Z-1360-2019 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: 3 units.
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
- 3 units
Product Description
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Reason for Recall
Devices were delivered without the required dry ice.
Distribution Pattern
Distribution to Latvia.
Code Information
LN 3P25-02; Lot 93284UIOO