Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1743-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.Recall Z-1728-2015 REASON Software anomaly...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1742-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing Recall...Read More

Company: Elekta Inc. Date of Enforcement Report 6/17/2015 Class lI: PRODUCT Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Recall Number Z-1719-2015 REASON Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2. RECALLING FIRM/MANUFACTURER Elekta Inc.,...Read More