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UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

FDA Recall #Z-1599-2023 — Class II — April 5, 2023

Recall #Z-1599-2023 Date: April 5, 2023 Classification: Class II Status: Ongoing

Product Description

UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

Reason for Recall

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

Recalling Firm

Beckman Coulter, Inc. — Miami, FL

Classification

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

Product Type

Devices

Product Quantity

306 units

Distribution

Worldwide Distribution

Code Information

UDI/DI 15099590735982, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6

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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