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Sources: EU EUDAMED, US FDA
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Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·September 18, 2012
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code JJW·April 20, 2020
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
FDA Recall
Terminated
·Quantimetrix Corporation·Product code JJW·December 21, 2017
Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.
FDA Recall
Terminated
·Quantimetrix Corporation·Product code JJW·June 1, 2007
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Recall
Terminated
·Thermofisher Scientive·Product code JJW·October 29, 2013
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·July 9, 2012
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
FDA Recall
Terminated
·Product code JJW·July 16, 2013
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
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
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJW·July 25, 2019
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
FDA Recall
Terminated
·International Remote Imaging Systems Inc·Product code JJW·April 29, 2005
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9401407, Siemens Medical Solutions, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007
Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007
Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9401316, Siemens Medical Solutions, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007