Recall Z-1738-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical an
| Date | Jun 9, 2014 (initiated Apr 10, 2014) |
| Status | Terminated |
| Reason | Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems. |
| Root cause | Software design |
| Action | Urgent Product Correction Letters (CL2014-114, dated 4/10/2014) were sent to all US customers and Foreign affiliates starting on 4/10/2014. The letter informed customers of the issue and provided required actions to be taken: Routinely monitor your Bypass module(s) -- If you detect a stoppage due to the software timing issue, follow the steps in the How to Detect the Bypass Module Time Issue and Release the Samples section on Page 2 of this notification. -- Complete the Confirmation of Receipt Form and return by 4/23/2014. -- Place this notification near each system or with your enGen (TM) |
| Quantity | Domestic - 31 units; Foreign - 77 units |
| Distribution | Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela |
| 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 |