7 results
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7ms
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Sources: EU EUDAMED, US FDA
PerkinElmer 226 Sample Collection Device
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·June 10, 2020
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·April 20, 2016
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·August 3, 2016
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·August 2, 2017
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
FDA Enforcement
Class III
·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·December 28, 2016