Associates of Cape Cod, Inc. - Fungitell Assay - Class 2 Recall
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diag...
Source: Medical Device Recalls - May 15, 2019 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BD Synapsys Microbiology Informatics Solution - Class 2 Recall
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2019 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Cepheid Respiratory Control Panel - Class 2 Recall
Cepheid Respiratory Control Panel (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2019 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - Difco Agar Noble, 500g bottle - Class 2 Recall
Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - BD - Class 2 Recall
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Adenovirus (20/11 & 2/6) - Class 2 Recall
Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Herpes Simplex Virus I - Class 2 Recall
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Herpes Simplex Virus II - Class 2 Recall
Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Varicella Zoster Virus - Class 2 Recall
Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - CD117, ckit (YR145) - Class 2 Recall
CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - SV40 (MRQ4) - Class 2 Recall
SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - HHV8 (13B10) - Class 2 Recall
HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Estrogen Receptor (EP1) - Class 2 Recall
Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Acumedia Manufacturers, Inc. - Acumedia Beef Extract Powder - Class 3 Recall
Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for mult...
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - EpiCenter Plus Microbiology Data Management System - Class 2 Recall
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act ...
Source: Medical Device Recalls - February 28, 2017 Category: Medical Equipment Source Type: alerts
