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.
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling Alinity i Ferritin Reagent Kits (List Number 07P6530) due to a manufacturing issue that can damage the bottle neck in some reagent cartridges. The affected lots were distributed to Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia. A total of 216 units are involved in this recall. When a bottle neck is damaged, it may cause a failure during the reagent loading process when the cartridge is used with the Alinity i instrument.
The affected lot/code numbers are: UDI/Lot Numbers (01)00380740131487 (17)190730(10)91532UI00/91532UI00 and (01)00380740131487 (17)190905(10)93238UI00/93238UI00. The source document does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US Distribution to states of: AR, FL, GA, MD, OK and VA. Quantity: 216 units Lot/code info: UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.