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Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

FDA Recall #Z-0958-2023 — Class III — November 24, 2022

Recall #Z-0958-2023 Date: November 24, 2022 Classification: Class III Status: Ongoing

Product Description

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Reason for Recall

Reaction vessels may contain a potential contaminant that could affect their optical performance.

Recalling Firm

Abbott Laboratories — Irving, TX

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

70 cases

Distribution

US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

Code Information

UDI-DI/Lots: 00380740129026/000586790 and 000586879

Status

Ongoing

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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