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enGen Laboratory Automation System
- Starting date:
- September 8, 2016
- 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-60438
Affected Products
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall pertaining to enGen Systems configured with a thermo scientific centrifuge module and TCAutomation (TCA) software versions 3.6.1 and below.
Ortho became aware of one confirmed instance of test results that were mis-associated with the wrong sample id (SID) and were reported prior to the enGen System detecting the SID mismatch.
Assay results are potentially associated with the wrong patient and reported out of the laboratory. This could lead to inappropriate intervention with the potential for serious injury to the patient. Ortho received no reports of patient injury due to this issue.
Affected products
enGen Laboratory Automation System
Lot or serial number
- J16XQH4J
- J41BCY4J
- J953244
- JCT20Q3J
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND