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Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration o...

FDA Recall #Z-1016-2019 — Class II — December 3, 2018

Recall #Z-1016-2019 Date: December 3, 2018 Classification: Class II Status: Ongoing

Product Description

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Reason for Recall

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Recalling Firm

Randox Laboratories Ltd. — Crumlin (North), N/A

Classification

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

Product Type

Devices

Product Quantity

85 kits

Distribution

US Distribution to states to: CA, ME. MI, and WV.

Code Information

498FR

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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