Microbiologics Inc - Helix Elite Inactivated Standard - Class 2 Recall
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2022 Category: Medical Devices Source Type: alerts
Abbott Molecular, Inc. - Abbott Alinity m - Class 2 Recall
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2022 Category: Medical Devices Source Type: alerts
Luminex Corporation - ARIES SARSCoV2 Assay - Class 2 Recall
ARIES SARS-CoV-2 Assay (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2022 Category: Medical Devices Source Type: alerts
North American Diagnostics - Oral Rapid SARSCoV2 Rapid Antigen Test Kit - Class 1 Recall
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2022 Category: Medical Devices Source Type: alerts
LumiraDx - SARSCoV2 Antibody (Ab) Test Strip - Class 2 Recall
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 23, 2022 Category: Medical Devices Source Type: alerts
LumiraDx - SARSCoV2 Antibody (Ab) Liquid Quality Control - Class 2 Recall
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 23, 2022 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, Inc. - AntiSARSCoV2 IgG Quantitative Reagent Pack - Class 2 Recall
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2022 Category: Medical Devices Source Type: alerts
NeuMoDx Molecular Inc - NeuMoDx Flu AB/RSV/SARSCoV2 Vantage Test Strip - Class 2 Recall
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2022 Category: Medical Devices Source Type: alerts
Woodside Acquisitions Inc. - Oral Rapid SARSCoV2 Antigen Rapid Test Kit - Class 1 Recall
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2022 Category: Medical Devices Source Type: alerts
Woodside Acquisitions Inc. - Joysbio SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold) - Class 1 Recall
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2022 Category: Medical Devices Source Type: alerts
PROTERIXBIO - ProterixBio SARSCoV2 (RBD) IgG Antibody Test - Class 2 Recall
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2022 Category: Medical Devices Source Type: alerts
MESA BIOTECH, INC - Accula SARSCoV2 Test, REF: COV4100 - Class 1 Recall
Accula SARS-CoV-2 Test, REF: COV4100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2022 Category: Medical Devices Source Type: alerts
USA Medical, LLC - Diagnostic Kit SARScCo V Antigen Rapid Test - Class 2 Recall
Diagnostic Kit SARS-cCo V Antigen Rapid Test (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2022 Category: Medical Devices Source Type: alerts
SML Distribution, LLC - Skippack Medical Lab SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test - Class 1 Recall
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2022 Category: Medical Devices Source Type: alerts
NeuMoDx Molecular Inc - Class 2 Recall
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2022 Category: Medical Devices Source Type: alerts
