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UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vit...

FDA Recall #Z-0985-2014 — Class II — November 26, 2013

Recall #Z-0985-2014 Date: November 26, 2013 Classification: Class II Status: Terminated

Product Description

UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Reason for Recall

The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

Recalling Firm

Beckman Coulter Inc. — Brea, CA

Classification

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

Product Type

Devices

Product Quantity

1 unit

Distribution

Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.

Code Information

Part Number A30260. Serial Numbers 900781.

Status

Terminated

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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