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Alinity i TSH Reagent Kit, List Number 07P4830

FDA Recall #Z-0664-2019 — Class II — November 21, 2018

Recall #Z-0664-2019 Date: November 21, 2018 Classification: Class II Status: Terminated

Product Description

Alinity i TSH Reagent Kit, List Number 07P4830

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.

Recalling Firm

Abbott Ireland Diagnostics Division — Co. Longford

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

678 units

Distribution

AR, FL, GA, MD, OK, VA

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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