BEUDAMED
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    Cios care fusion system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DAP·May 22, 2012

    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DAP·June 7, 2012

    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code DAP·December 3, 2004

    Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·April 3, 2006

    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code DAP·April 17, 2013

    Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·April 3, 2006

    Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·July 29, 2005

    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DAP·November 11, 2015

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code GAD·November 28, 2019

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code KDG·January 11, 2019

    The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DAD·May 16, 2018

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·April 4, 2017

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·November 3, 2015

    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021

    FDA Recall
    Terminated ·Inova Diagnostics Incorporated·Product code DAK·October 28, 2009

    ASR TAP SLV ADAP 12/14 +5, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR TAP SLV ADAP 11/13 +3, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR TAP SLV ADAP 11/13 +9, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010