Ortho-Clinical enGen Laboratory Automation System Recalled for Electrical Cable Hazard
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems because an electrical cable may loosen and cause sample fluid to splash.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential sample contamination and equipment malfunction, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the enGen (TM) Laboratory Automation System configured with the Thermo Scientific Recapper Module. The recall involves 19 units in the United States and 30 units in foreign countries. The affected systems were distributed across 17 US states and 16 foreign countries.
The recall is due to a defect where the electrical cable supplying power to the cap vibratory feeder may loosen from its position above the support plate and migrate underneath it. If this occurs, uncapped sample tubes may strike the cable, causing sample fluid such as serum to splash into other tubes or onto the under carriage of the support plate.
No specific instructions for consumers are provided in the source text, as the product is a laboratory automation system. The recall is classified as Class II by the FDA.
The recalled product
- Product
- enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- US Serial Numbers: JFBX395J
- GBX395J
- J953252
- JJXBQW4J
- J3RHC23J
- J86PWC5J
- J5LQ6Q2J
- JFCM073J
- J54FC01J
- J5J4B45J
- J7KSC15J
- J4HX7S4J
- JGWXQ52J
- J953221
- JG7BFB5J
- JHPKG25J
- JCXL941J
- J736BM4J
- JFXCBG3J
- -- Foreign Serial Numbers: J89133 (VAS)
Distribution
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