BEUDAMED
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    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CFF·January 28, 2004

    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code OTT·October 2, 2015

    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·November 18, 2015

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code LHL·February 15, 2017

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 5, 2017

    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code LHL·February 15, 2017

    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 5, 2017

    Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·October 9, 2013

    Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·October 9, 2013

    PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code JQW·January 20, 2011

    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

    FDA Recall
    Terminated ·Data Innovations, LLC·Product code JQP·August 29, 2018

    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics LLC·October 23, 2013

    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

    FDA Recall
    Terminated ·Sekisui Diagnostics LLC·Product code LLH·September 16, 2013

    QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.

    FDA Enforcement
    Class II ·Terminated·Inova Diagnostics Incorporated·April 4, 2018

    QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.

    FDA Recall
    Terminated ·Inova Diagnostics Incorporated·Product code JJE·January 26, 2018

    American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code EFQ·March 31, 2016

    Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876. 12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893. 13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058. 14) Regard, LAP, Item 800096005, Lot # 83139. 15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251. 16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138. 17) Regard, LAP CHOLE, Item 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88

    FDA Recall
    Terminated ·ROi CPS LLC·Product code EFQ·November 9, 2020

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IFB·June 4, 2018

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

    FDA Recall
    Terminated ·Steris Corporation·Product code EFQ·March 22, 2022

    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.

    FDA Recall
    Terminated ·Separation Technology, Inc.·Product code IFB·March 13, 2013