Recall Z-1831-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsyste
| Date | Mar 28, 2011 (initiated Jan 27, 2011) |
| Status | Terminated |
| Reason | A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen" Laboratory Automation System using TCAutomation" Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification. |
| Root cause | Software design |
| Action | The firm, Ortho Clinical Diagnostics (OCD), sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated January 27, 2011, by Federal Express overnight mail to all customers. Foreign affiliate consignees/customers were notified by email informing them of the issue on the same day. The letter described the problem, product and actions to be taken. The firm also included temporary procedures to help prevent the occurrence of the software anomaly. The customers were instructed to follow the enclosed Procedure to STOP the Automation System and/or Bypass Module; complete and return the attached C |
| Quantity | 63 units |
| Distribution | Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.