Recall record at a glance
| Official record | Z-1738-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ortho-Clinical Diagnostics |
| Report date | Jun 18, 2014 |
| Recall initiation date | Apr 10, 2014 |
| Quantity | Domestic - 31 units; Foreign - 77 units |
| Location | Rochester, NY, United States |
Official product description
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 and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.
Why the product was recalled
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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
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