Recall Z-0665-2019— Abbott Ireland Diagnostics Division

Name: FDA recall Z-0665-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-21

Class II · Terminated

Class II FDA medical device recall by Abbott Ireland Diagnostics Division, initiated 2018-11-21, terminated 2021-04-01. It names one FDA 510(k) clearance: K173122. Product: Alinity i Free T4 Reagent Kit, List Number 07P7030. 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..

Recalling firm: Abbott Ireland Diagnostics Division
Classification: Class II
Status: Terminated
Initiated: 2018-11-21
Terminated: 2021-04-01
Firm location: Co. Longford, Ireland

510(k) clearances named in this recall

1 on FDA's record

K173122 — Abbott Architect Free T4Abbott Laboratories·cleared 2017-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alinity i Free T4 Reagent Kit, List Number 07P7030

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.