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VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of ...

FDA Recall #Z-0735-2022 — Class II — December 10, 2021

Recall #Z-0735-2022 Date: December 10, 2021 Classification: Class II Status: Ongoing

Product Description

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Reason for Recall

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

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

4125 units

Distribution

Domestic distribution nationwide. Foreign distribution to Canada.

Code Information

UDI 10758750006786 Lot 1039734

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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