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The company also said that it received ISO 13485:2016 certification for its Mosaiq platform and it has filed for CE marking for its initial immunohematology microarray.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
The recall affects certain lot numbers and package sizes that were manufactured and distributed between January 12 and October 29 of this year and involves more than 1.1 million packages.
The instrument is a centrifuge/reader combo that automatically reads and transfers blood type and antibody screening results to patient data management software.
The ID Core XT is the second molecular assay approved by the FDA for use in transfusion medicine and the first to report genotypes as final results.
Its platform is being developed for several medical conditions using separate modules to measure cells, proteins, nucleic acids, enzymes, and small molecules.
In May, Kurin sued Magnolia for allegedly making false claims about the efficacy and regulatory status of its Steripath blood culture collection system.
The battery-operated, hand-held device uses a broad-spectrum photometric method to provide accurate hemoglobin measurements in about one second.
The company's Life Sciences segment was up 17 percent year over year, while its Diagnostics business grew 8 percent.
The assay is designed to quickly determine if a patient may be developing thrombocytopenia while being treated with the blood thinner heparin.
The researchers described the development of a venipuncture robot that addresses safety challenges associated with routine vein punctures for drawing blood.
The Early Sepsis Indicator is intended to provide clinicians information about sepsis and the risk of developing sepsis in patients in acute care settings.
The study found that for some patients the standard practice of performing a second confirmatory blood test is not necessary, which could streamline care.
Elizabeth Holmes also stepped down from her position as Theranos CEO on Friday, to be replaced by the company's general counsel David Taylor.
Kurin alleges Magnolia has made false claims about its technology’s false-positive rates and contamination rates, as well as misleading claims about FDA clearance.
University of Tübingen researchers have identified a metabolite that could help uncover sample handling errors contributing to preanalytical variability.
Echo Lumena is Immucor's fifth-generation immunohematology instrument, and with the fully automated NEO platform, they offer a standardized workflow solution for laboratories.
The firm said that its system combines many of the analytical strengths of a higher-volume instrument with the ease of a table-top analyzer.
According to the firm's CEO, there's a need for a portable hemoglobin measurement system that can deliver lab-quality results in the clinic within seconds.
The push-button device, which works by firing an array of microneedles into an individual's arm, was cleared by the FDA last year.