Ortho-Clinical Diagnostics, Inc. - Ortho Clinical Diagnostics VITROS Immunodiagnostic Products SARSCoV2 Antigen Reagent Pack - Class 2 Recall
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
LumiraDx - LumiraDx SARSCoV2 Ag Test Strip Kit - Class 2 Recall
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 18, 2021 Category: Medical Devices Source Type: alerts
LumiraDx - LumiraDx SARSCoV2 Ag Test Strip Kit US EUA (48 Tests / EN) - Class 2 Recall
The LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips (hereafter referred to as Test Strips) are to be used with the LumiraDx Platform. The LumiraDx Platform is a point of care system for professional use which is used for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 18, 2021 Category: Medical Devices Source Type: alerts
Sky Medical Supplies and Equipments LLC - AntIbody to SARSCoV2, (Colloidal Gold) for IgG/IgM Diagnostic Kit - Class 2 Recall
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2021 Category: Medical Devices Source Type: alerts
Confirm Biosciences Inc - Orient Gene COVID 19 IgG/ IgM Rapid Test Cassette - Class 2 Recall
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2021 Category: Medical Devices Source Type: alerts
Confirm Biosciences Inc - Healgen COVID19 IgG/IgM Rapid Test Cassette - Class 2 Recall
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2021 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BioGX SARSCoV2 Reagents for BD MAX System - Class 2 Recall
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Qiagen Sciences LLC - QIAreach SARSCoV2 Antigen Test (60) - Class 2 Recall
SARS-CoV-2 Antigen Test (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - ACCESS SARSCoV2 IgG QC - Class 2 Recall
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2021 Category: Medical Devices Source Type: alerts
VISBY MEDICAL INC - visby medical COVID19 Test kit - Class 2 Recall
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2021 Category: Medical Devices Source Type: alerts
Ansh Labs, LLC - AnshLabs SARSCoV2 IgM ELISA (Capture) - Class 2 Recall
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2021 Category: Medical Devices Source Type: alerts
Biomeme, Inc. - Biomeme SARSCoV2 RealTime RTPCR Test - Class 2 Recall
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomeme s M1 Sample Prep Cartridge for RNA extraction, Biomeme s SARS-CoV-2 Go-Strips assay, and Biomeme s portable Franklin" Real-Time qPCR Thermocycler. Franklin s companion mobile app, Biomeme Go, scans tests, runs P...
Source: Medical Device Recalls - December 2, 2020 Category: Medical Devices Source Type: alerts
VEO DIAGNOSTICS, LLC - ACCEL ELISA COVID19 Test - Class 2 Recall
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2020 Category: Medical Devices Source Type: alerts
Ortho Clinical Diagnostics Inc - VITROS Immunodiagnostic ProductsSARSCoV2 IgG Calibrator - Class 2 Recall
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2020 Category: Medical Devices Source Type: alerts
Ortho Clinical Diagnostics Inc - VITROS Immunodiagnostic Products AntiSARSCoV2 IgG Control - Class 2 Recall
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2020 Category: Medical Devices Source Type: alerts
