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EnGen Laboratory Automation System (2014-03-21)
- Starting date:
- March 21, 2014
- Posting date:
- April 14, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39023
Recalled Products
EnGen Laboratory Automation System
Reason
Ortho Clinical Diagnostics internal testing has determined that when 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 prior to completion of the necessary pending action. A delay in patient test result(s) reporting could occur. This affects engen laboratory automation systems configured with Data Innovations, LLC Instrument Manager V8.06.
Affected products
EnGen Laboratory Automation System
Lot or serial number
- JIM340432
- JIM340814
- JIM341055
- JIM341130
Model or catalog number
EnGen
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND