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BD Viper LT software, version 3.00H

FDA Recall #Z-1866-2017 — Class II — December 14, 2015

Recall #Z-1866-2017 Date: December 14, 2015 Classification: Class II Status: Terminated

Product Description

BD Viper LT software, version 3.00H

Reason for Recall

BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.

Recalling Firm

Bd Diagnostic — Sparks, MD

Classification

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

Product Type

Devices

Product Quantity

2

Distribution

2 US customers, 0 Ex-US regions, and 0 distributors 0.

Code Information

Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H

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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