NeoBase Succinylacetone Assay Solution
Wallac Oy · Model 3042-0020 · UDI-DI 06438147295708
2
510(k) clearances
3
Adverse events
3
Recalls
1
Facilities
Description
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS).
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.