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NeoBase 2 Succinylacetone Assay Solution

Wallac Oy · Model 3046-0010 · UDI-DI 06438147356829

NQL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit and the NeoBase2 Non-derivatized Assay Solutions to extract succinylacetone from 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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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.