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MP Biomedicals LLC

Mp Biomedicals, LLC · Model 07596307 · UDI-DI 00817830023235

JNO
7
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

NEONATAL TRYPSIN MW 20 PLATE ELISA KIT

Recalls

DateFirmReason
2017-09-25PerkinElmer Life and Analytical Sciences, Wallac, OYThe Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in
2007-02-15Diasorin Inc.Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)

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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.