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Recall Observatory FDA recall evidence

Device product

Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

Z-0666-2019

November 21, 2018

Class II

Product summary

Firm
Abbott Ireland Diagnostics Division
Event
Event 81632
Status
Terminated
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0666-2019

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)00380740160616 (17)190807(10)92056UI00 / 92056UI00

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.