10 results
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6ms
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Sources: EU EUDAMED, US FDA
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·October 30, 2013
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Enforcement
Class III
·Ongoing·APN Health LLC·December 20, 2023
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
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021