Company: PerkinElmer Health Sciences IncDate of Enforcement Report: 8/16/2014 Class lI: PRODUCT PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. Recall Number Z-2166-2014 REASON Potential for demographic information...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 8/13/2014 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) — 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 Slides (colorimetric endpoint, rate, ion-selective electrode, and...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 8/13/2014 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System — 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600,...Read More

/docs/FDAHomeUseDesignConsiderationGuidance0814.pdfRead More

Company: Brainlab AG.Date of Enforcement Report: 8/13/2014 Class lI: PRODUCT ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated....Read More