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QMS Tacrolimus Calibrators, Product code 10015573

FDA Recall #Z-0712-2024 — Class II — November 21, 2023

Recall #Z-0712-2024 Date: November 21, 2023 Classification: Class II Status: Ongoing

Product Description

QMS Tacrolimus Calibrators, Product code 10015573

Reason for Recall

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

Recalling Firm

Ortho-Clinical Diagnostics, Inc. — Rochester, NY

Classification

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

Product Type

Devices

Product Quantity

10 sales units US; 1 sales unit OUS

Distribution

Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.

Code Information

No UDI Lot 74859619, Expiry 11-May-2024

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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