NeoBase Non-derivatized Assay Solutions
Wallac Oy · Model 3041-0020 · UDI-DI 06438147295692
2
510(k) clearances
3
Adverse events
3
Recalls
1
Facilities
Description
This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper. This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution.
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.