BEUDAMED
    14 results · 45ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    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

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·August 23, 2011

    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

    Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIF·August 5, 2011

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code JJW·February 6, 2014

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DLJ·February 6, 2014

    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 Recall
    Terminated ·Lin-Zhi International Inc·Product code DJG·February 18, 2014

    Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·October 11, 2011

    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 Recall
    Terminated ·Lin-Zhi International Inc·Product code LAS·October 3, 2013

    Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIS·September 8, 2011

    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 Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    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