The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instru
FDA device recall Z-1831-2011 · posted 2011-03-28 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- 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.
- Action taken
- 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 Confirmation of Receipt - Important Response Required form by February 4, 2011, via fax to: Ortho Clinical Diagnostics, 1-888-557-3759 or 1-585-453-4110, and display this communication near the enGen Laboratory Automation System to ensure compliance by all operators until updated TCAutomation Laboratory Automation System software is installed. A Technical Bulletin will be sent to customers in the near future to be stored with user documentation. Ortho will implement a TCAutomation Laboratory Automation System software change in the near future to resolve this anomaly. If you have any questions regarding this notification, please call Customer Technical Services at 1-800-421-3311 (Options 1, 2).
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 63 units
- Distribution
- Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.
- Date initiated
- 2011-01-27
- Date posted
- 2011-03-28
- Date terminated
- 2017-05-09
- Location
- Rochester, NY
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