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ENGEN LABORATORY AUTOMATION SYSTEM (2015-05-07)
- Starting date:
- May 7, 2015
- Posting date:
- June 3, 2015
- 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-53627
Recalled Products
A. ENGEN LABORATORY AUTOMATION SYSTEM
Reason
Under certain conditions, when an enGen Laboratory Automation System (enGen system) is configured with a recapper module, there is a potential for recapper caps for use with the recapper module to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. There is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the rack entry/exit or rack exit module. These situations may result in splashing of bio-hazardous fluid, and sample cross-contamination may occur if there is an uncapped tube in the rack.
Affected products
A. ENGEN LABORATORY AUTOMATION SYSTEM
Lot or serial number
- J16XQH4J
- JCT20Q3J
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND