Z-0669-2019 Class II Terminated
FDA device recall Z-0669-2019 was initiated by Abbott Ireland Diagnostics Division on November 21, 2018 and is designated Class II. Reason for recall: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it m… The recall status is terminated (terminated April 1, 2021). Affected quantity: 760 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 21, 2018
- Termination Date
- April 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 760 units
Product Description
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Reason for Recall
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Distribution Pattern
AR, FL, GA, MD, OK, VA
Code Information
UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00