Abbott Ireland Diagnostics Division: Medical Device Recall in 2019 - (Recall #: Z-0666-2019)

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 Total Beta-hCG Reagent Kit, List Number 07P5121

Product Classification:

Class II

Date Initiated: November 21, 2018

Date Posted: January 2, 2019

Recall Number: Z-0666-2019

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: 27 units

Code Information:

UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00

Distribution Pattern:

AR, FL, GA, MD, OK, VA

Voluntary or Mandated:

Voluntary: Firm initiated