NeoBase 2 Non-derivatized MSMS kit
Wallac Oy · Model 3044-001U · UDI-DI 06438147356812
NQL
Prescription
2
510(k) clearances
3
Adverse events
3
Recalls
1
Facilities
Description
NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid 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.