Versea Diagnostics LLC - CareStart COVID19 Antigen Rapid Diagnostic Test - Class 2 Recall
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
TRADITIONAL CHINESE MEDICINE HEALTH CARD AND TCM EPIDEMIC PREVENTION CARD (natural herbal antibacterial card and tcm magic card) powder [Chuanzongbao (Hangzhou) intangible cultural heritage protection Co., Ltd]
Updated Date: Wed, 21 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 21, 2021 Category: Drugs & Pharmacology Source Type: alerts
TRADITIONAL CHINESE MEDICINE HEALTH CARD AND TCM EPIDEMIC PREVENTION CARD (natural herbal antibacterial card and tcm magic card) powder [Chuanzongbao (Hangzhou) intangible cultural heritage protection Co., Ltd]
Updated Date: Mon, 19 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 19, 2021 Category: Drugs & Pharmacology Source Type: alerts
Remel Europe Ltd. - Thermo Scientific Remel Bordetella pertussis - Class 2 Recall
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2020 Category: Medical Devices Source Type: alerts
Remel Inc - Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum - Class 2 Recall
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 27, 2017 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - Class 2 Recall
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Labo...
Source: Medical Device Recalls - December 14, 2016 Category: Medical Equipment Source Type: alerts
Alere Scarborough, Inc. dba Binax, Inc. - Alere i flu, Alere i, Alere Influenza A & B - Class 2 Recall
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended...
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts
Alere Scarborough, Inc. dba Binax, Inc. - Alere i Influenza A & B - Class 2 Recall
Alere i Influenza A & B Product Usage: The Alere i Influenza A & B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza...
Source: Medical Device Recalls - May 27, 2015 Category: Medical Equipment Source Type: alerts
Nanosphere, Inc. - Class 2 Recall
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying speci...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts
Nanosphere, Inc. - Class 2 Recall
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: ...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts
Nanosphere, Inc. - Class 2 Recall
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, ...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts
Nanosphere, Inc. - Nanosphere Verigene - Class 3 Recall
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is b...
Source: Medical Device Recalls - August 9, 2014 Category: Medical Equipment Source Type: alerts
Nanosphere, Inc. - Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN) - Class 2 Recall
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloods...
Source: Medical Device Recalls - August 9, 2014 Category: Medical Equipment Source Type: alerts
Focus Diagnostics Inc - Simplexa Flu A/B &38; RSV Direct - Class 2 Recall
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosi...
Source: Medical Device Recalls - July 2, 2014 Category: Medical Equipment Source Type: alerts
Focus Diagnostics Inc - Simplexa Flu A/B & RSV Direct assay - Class 2 Recall
Simplexa" Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans ...
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts
