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NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. ...

FDA Recall #Z-0687-2013 — Class II — November 26, 2012

Recall #Z-0687-2013 Date: November 26, 2012 Classification: Class II Status: Terminated

Product Description

NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Reason for Recall

Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

Recalling Firm

Perkinelmer — Waltham, MA

Classification

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

Product Type

Devices

Product Quantity

819 kits (10 plates/kit)

Distribution

Nationwide Distribution.

Code Information

Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453

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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