Z-2208-2019 Class II Terminated
FDA device recall Z-2208-2019 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 ma… The recall status is terminated (terminated March 25, 2021). Affected quantity: 216 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- November 21, 2018
- Termination Date
- March 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216 units
Product Description
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
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
US Distribution to states of: AR, FL, GA, MD, OK and VA.
Code Information
UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00