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Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic...

FDA Recall #Z-0946-2015 — Class II — November 24, 2014

Recall #Z-0946-2015 Date: November 24, 2014 Classification: Class II Status: Terminated

Product Description

Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

Reason for Recall

Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Newark, DE

Classification

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

Product Type

Devices

Product Quantity

1230

Distribution

Worldwide Distribution: US (nationwide) and country of: Canada.

Code Information

Lot 4FD085, exp. 12-01-2014

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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