Recall Z-0941-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
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 (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS
| Date | Feb 9, 2014 (initiated Oct 8, 2013) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems. |
| Root cause | Software design |
| Action | Ortho Clinical Diagnostics (OCD), issued an Urgent Product Correction Notification letter dated October 7, 2013 and on December 17, 2013 to their customers via Federal Express or via US Postal Service. The letter identified the affected product, problem and actions. The notices advise the customers to ensure that all required data elements are entered and in the correct format if using the autoverification or custom rules for the referenced enGen Laboratory Automation Systems. OCD trained service representatives will contact all affected customers. Customers with questions may call the Cus |
| Quantity | 8 units |
| Distribution | Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.