Reported Jan 23, 2013 · Terminated

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for…

Perkinelmer

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Perkinelmer · 940 Winter Street · Waltham, MA · 02451

Is this the product you have?

  • NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
  • MASS SPECTROMETRY KIT Product Number3026-0030. 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
Lot codes and dates
  • Lot Numbers
    • 617341
    • 619236
Amount recalled
180 kits (20 plates/kit)

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 7, 2014 · Data as of Sep 19, 6:13 PM UTC

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