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Recall Observatory FDA recall evidence

Device product

Alinity i TSH Reagent Kit, List Number 07P4830

Z-0664-2019

November 21, 2018

Class II

Product summary

Firm
Abbott Ireland Diagnostics Division
Event
Event 81632
Status
Terminated
Classification
Class II
Quantity
678 units
Official record key
device-enforcement:Z-0664-2019

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.