NeoGram Derivatized Assay Solutions
Wallac Oy · Model 3030-0020 · UDI-DI 06438147283842
1
510(k) clearances
3
Adverse events
3
Recalls
1
Facilities
Description
The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.
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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Get your free API keyRead the docsData 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.