Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-0967-2015 REASON Software Anomaly: the firm has identified...Read More

Company:Phadia US IncDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing,...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 5600 Integrated System, Catalog Number 6802413, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents....Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD — Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products...Read More

Company:Brainlab AGDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT Plan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Recall Number Z-0956-2015 REASON iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning...Read More