Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the...Read More

Company:Sysmex America Inc Date of Enforcement Report:2/19/2014 Class lI: PRODUCT The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. Recall Number Z-0949-2014 REASON The current Century...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/19/2014 Class lI: PRODUCT Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for...Read More

Company:Neuro Kinetics, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Recall Number Z-0966-2014 REASON The data provided on the Normative Data Template CD for use with the I-Portal devices has not...Read More

Company:Mckesson Information Solutions LLCDate of Enforcement Report:2/19/2014 Class lI: PRODUCT Horizon Medical Imaging, Picture Archive Communication System (PACS). Recall Number Z-0976-2014 REASON Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.. RECALLING FIRM/MANUFACTURER Mckesson Information Solutions LLC,...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation 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...Read More

Company: Bio-Rad Laboratories, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale}...Read More