R & D Systems, Inc. - Quantikine IVD Human sTfR Immunoassay - Class 2 Recall
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2021 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension Ferritin (FERR) Flex reagent cartridge - Class 2 Recall
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2019 Category: Medical Devices Source Type: alerts
R & D Systems, Inc. - Quantikine IVD Human sTfR Immunoassay - Class 3 Recall
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2019 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack - Class 2 Recall
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2018 Category: Medical Devices Source Type: alerts
Tosoh Bioscience Inc - STAIA PACK FerFerritin - Class 2 Recall
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts
Encore Medical, Lp - Cobalt HV Bone Cement - Class 2 Recall
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revis...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts
Encore Medical, Lp - Cobalt HV Bone Cement with Gentamicin - Class 2 Recall
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic ...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts
Encore Medical, Lp - Cobalt HV Bone Cement - Class 2 Recall
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revis...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts
Encore Medical, Lp - Cobalt MV Bone Cement with Gentamicin - Class 2 Recall
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic ...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics - IMMULITE /IMMULITE 1000 Folic Acid - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 25, 2013 Category: Medical Equipment Source Type: alerts
Assuramed - Hemoccult II SENSA elite - Class 2 Recall
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a ...
Source: Medical Device Recalls - September 14, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. dba Renal Solutions - 2008 MeDS Pump, Venofer(R) Pump - Class 2 Recall
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2013 Category: Medical Equipment Source Type: alerts
