enGen Laboratory Automation System (2016-03-18) — recall 54727
Health Canada — Medical Devices · Canada · 2016-04-07 · Type II
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Reported risk: 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.
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