Recall Z-1741-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- 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 Sl
| Date | Jun 10, 2014 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5. |
| Root cause | Software Design Change |
| Action | Ortho Clinical Diagnostics sent an Important Product Correction Notification dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On April 17, 2014, foreign affiliates were informed by e-mail of the issue and instructed to notify their customers of the issue and actions. The letters instruct customers: to ensure that samples prematurely routed to Check are detected and processed appropriately, please monitor completion of all pending tests following standard laboratory practice. Customers were inform |
| Quantity | Domestic: 6 units, Foreign: 3 units |
| Distribution | Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc., Nov 13, 2006 |