BEUDAMED
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    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code MJQ·July 4, 2008

    NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).

    FDA Recall
    Terminated ·Biomerieux, Inc.·Product code JJQ·February 26, 2004

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code JJQ·January 12, 2011

    Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a Johnson & Johnson Company, Milpitas California 95035, For Sale Outside of the USA and Canada, Lot 1666680A Exp. 2003-11. Product is packed two vials of 25 strips per vial.

    FDA Recall
    Terminated ·Product code JJQ·October 8, 2002

    Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips, LIFESCAN, a Johnson & Johnson Company, Milpitas, CA 95035, USA, Lot: E-169380A, Exp: 2003-01.

    FDA Recall
    Terminated ·Product code JJQ·October 8, 2002

    Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJQ·February 15, 2005

    Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code JJQ·December 5, 2008

    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.

    FDA Recall
    Terminated ·Otsuka America Pharmaceutical, Inc.·Product code JJQ·January 18, 2008

    BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJQ·February 15, 2005

    BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.

    FDA Recall
    Terminated ·BioTek Instruments, Inc. Highland Park/Box·Product code JJQ·March 12, 2009

    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015