FDA Enforcement
Class II
Terminated
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.
Recall: Z-2208-2019
·
Reported August 14, 2019
Enforcement
- Recall Number
- Z-2208-2019
- Event ID
- 83341
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Ireland Diagnostics Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2019
- Initiation Date
- November 21, 2018
- Classification Date
- August 7, 2019
- Termination Date
- March 25, 2021
- Address
- Lisnamuck, N/A, Co. Longford, N/A, N/A, Ireland
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
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.
Code Info
UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00
Distribution
US Distribution to states of: AR, FL, GA, MD, OK and VA.
Quantity
216 units