Boston Scientific Corporation - SpaceOAR System - Class 2 Recall
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2022 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - SpaceOAR Vue System - Class 2 Recall
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2022 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000, Third Generation PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000 Third Generation PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 2000 PSA Assay - Class 2 Recall
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal exa...
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000 PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or ...
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Qualigen Inc - FastPack Vitamin D Immunoassay - Class 2 Recall
FastPack¿ Free T4 Immunoassay FastPack¿ Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D K123983 Vitamin D The FastPack¿ Vitamin D Immunoassay is intended for the quantitative determination of FastPack¿ Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack¿ Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2013 Category: Medical Equipment Source Type: alerts

Qualigen Inc - FastPack Total PSA Immunoassay - Class 2 Recall
FastPack¿ Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. K994419 Total PSA FastPack¿ Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack¿ Total PSA Immunoassay is designed for use with the FastPack¿ System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics - IMMULITE - Class 2 Recall
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction w...
Source: Medical Device Recalls - August 24, 2013 Category: Medical Equipment Source Type: alerts