Recall record at a glance
| Official record | Z-1677-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ortho-Clinical Diagnostics |
| Report date | Jun 11, 2014 |
| Recall initiation date | Mar 20, 2014 |
| Quantity | Domestic: 20 units, Foreign: 61 units |
| Location | Rochester, NY, United States |
Official product description
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) 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 (TM) 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.
Why the product was recalled
Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
Distribution information
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the 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
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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