Home / Recalls / Perkinelmer / Z-0686-2013

Z-0686-2013 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

Recall Details

Product Type
Devices
Report Date
January 23, 2013
Initiation Date
November 26, 2012
Termination Date
March 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 kits (20 plates/kit)

Product Description

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.

Reason for Recall

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

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Numbers: 617341, 619236

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