Abbott Ireland Diagnostics Division: Medical Device Recall in 2019 - (Recall #: Z-0664-2019)

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 TSH Reagent Kit, List Number 07P4830

Product Classification:

Class II

Date Initiated: November 21, 2018

Date Posted: January 2, 2019

Recall Number: Z-0664-2019

Event ID: 81632

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: 678 units

Code Information:

UDI/Lot Numbers: (01)00380740131159 (17)190710(10)90061UI00 / 90061UI00 (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00 (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00

Distribution Pattern:

AR, FL, GA, MD, OK, VA

Voluntary or Mandated:

Voluntary: Firm initiated