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NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit

Wallac Oy · Model 3026-0030 · UDI-DI 06438147283835

NQL

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.

Recalls

Date	Firm	Reason
2017-11-02	PerkinElmer Life and Analytical Sciences, Wallac, OY	There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling
2012-11-26	Perkinelmer	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
2005-03-11	Perkin Elmer Life And Analytical	Pump failure may effect data integrity

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.