Abbott Ireland Diagnostics Division: Medical Device Recall in 2019 - (Recall #: Z-2208-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 21, 2018

Date Posted: August 14, 2019

Recall Number: Z-2208-2019

Event ID: 83341

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.

Status: Terminated

Product Quantity: 216 units

Code Information:

UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00

Distribution Pattern:

US Distribution to states of: AR, FL, GA, MD, OK and VA.

Voluntary or Mandated:

Voluntary: Firm initiated