15 results
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6ms
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Sources: EU EUDAMED, US FDA
AIA-PACK TPOAb CONTROL SET
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·June 7, 2017
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·August 22, 2018
AIA-PACK TgAb CONTROL SET
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·June 7, 2017
CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
FDA Enforcement
Class III
·Terminated·Tosoh Smd Inc·January 1, 2020
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·April 2, 2014
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·December 4, 2013
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·May 8, 2019
Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·February 6, 2013