Bio-Rad Laboratories, Inc. - BioPlex 2200 Syphilis Total & RPR - Class 2 Recall
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2022 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc. - BioPlex 2200 Syphilis Total & RPR - Class 2 Recall
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2022 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc. - BioPlex 2200 Syphilis Total & RPR - Class 2 Recall
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc. - BioPlex 2200 Syphilis Total & RPR - Class 2 Recall
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc - Class 2 Recall
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2021 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc. - BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum - Class 2 Recall
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
Randox Laboratories Ltd. - Rheumatoid Factor Calibrators - Class 2 Recall
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably q...
Source: Medical Device Recalls - November 5, 2019 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories - BioPlex 2200 Syphilis IgG Control Set - Class 2 Recall
BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Clark Laboratories, Inc. (dba,Trinity Biotech USA) - Captia (TM) Syphilis IgM Capture - Class 3 Recall
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2014 Category: Medical Equipment Source Type: alerts
LumiQuick Diagnostics Inc. - Syphilis Test Card (Serum) - Class 2 Recall
Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2014 Category: Medical Equipment Source Type: alerts
LumiQuick Diagnostics Inc. - Syphilis Test Strip (Serum - Class 2 Recall
Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2014 Category: Medical Equipment Source Type: alerts
LumiQuick Diagnostics Inc. - Syphilis Test Card Whole Blood(Serum) - Class 2 Recall
Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2014 Category: Medical Equipment Source Type: alerts
Clark Laboratories, Inc. (dba,Trinity Biotech USA) - Captia Syphilis IgG - Class 2 Recall
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 27, 2013 Category: Medical Equipment Source Type: alerts
