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enGen Laboratory Automation System (2016-03-18)
- Starting date:
- March 18, 2016
- Posting date:
- April 7, 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-57840
Affected products
A. enGen Laboratory Automation System
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall pertaining to the enGen Laboratory Automation System configured with Thermo Scientific Recapper Module due to the possibility that the electrical cable that supplies power to the cap Vibratory Feeder of the Recapper Module may loosen from its correct position above the Vibration Feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
Affected products
A. enGen Laboratory Automation System
Lot or serial number
J16XQH4J
J953244
JCT20Q3J
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND