Biocare Medical, LLC - URO3 Triple Stain (CD44 p52 CK20) - Class 2 Recall
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining o...
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - iView DAB Detection Kit w/o Secondary Antibody - Class 1 Recall
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2018 Category: Medical Devices Source Type: alerts
Stanbio Laboratory, LP - Power adapter for the HemoPoint H2 meter, Model G3000 series - Class 2 Recall
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Roche Diagnostics Hematology - cobas m 511 integrated hematology analyzer - Class 2 Recall
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports...
Source: Medical Device Recalls - July 27, 2018 Category: Medical Devices Source Type: alerts
Clarity Diagnostics Llc - Clarity Urocheck 10SG Urinalysis Strips - Class 3 Recall
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following are...
Source: Medical Device Recalls - July 25, 2018 Category: Medical Devices Source Type: alerts
Immuno-Mycologics, Inc - Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) - Class 2 Recall
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - BD Vacutainer Plus Plastic Citrate Blood Collection Tube (Catalog Reference 364305) - Class 2 Recall
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - BD Vacutainer Plus Plastic Citrate Blood Collection Tube - Class 2 Recall
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (Catalog Reference 366560) - Class 2 Recall
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2018 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Jaundice Meter JM103 - Class 1 Recall
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Jaundice Meter JM105 - Class 1 Recall
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - BD Vacutainer SST Plus Tubes - Class 2 Recall
The Vacutainer Plus SST Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer Plus SST Tubes consist of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts
ARNICOOL (Menthol) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: May 21, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 21, 2018 Category: Drugs & Pharmacology Source Type: alerts
NUMB520 (Lidocaine) Liquid [Clinical Resolution Laboratory, Inc.]
Updated Date: May 21, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 21, 2018 Category: Drugs & Pharmacology Source Type: alerts
