5 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.
FDA Recall
Terminated
·Lumitex Inc·Product code FDG·July 1, 2009
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001
FDA Recall
Terminated
·Lumitex Inc·Product code LBI·December 11, 2019
xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
FDA Recall
Terminated
·Luminex Corporation·Product code NTI·May 24, 2011
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
FDA Recall
Open, Classified
·Luminex Molecular Diagnostics Inc·Product code QLT·September 5, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
FDA Recall
Open, Classified
·Luminex Molecular Diagnostics Inc·Product code OCC·September 5, 2024