Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1724-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.

Product Classification:

Class II

Date Initiated: May 6, 2015

Date Posted: June 17, 2015

Recall Number: Z-1724-2015

Event ID: 71174

Reason for Recall:

Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may 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. Sample cross-contamination may occur with an uncapped tube in the rack.

Status: Terminated

Product Quantity: 45 units worldwide (Domestic: 19 units, Foreign: 26)

Code Information:

Serial Numbers: J89134, JIM341226, 341516, JIM342964, JIM340432, JIM340814, IM341243, JIM336912, J271265, J271369, J271372, J271267, J85208, JIM342217, J7023890, J7023841, J7025007, J7024894, J7023648, J7021530, J57662, J8006290, J75685, J30370, J3055510, J3055507, JIM341820, JIM341679, JIM341174, JIM340667, JIM-341592, JIM336957, JIM341477, JIM336855, JIM334236, JIM341415, JIM341392, JIM340934, JIM336167, JIM342249, JIM341750, JIM341426, JIM334527, JIM341021, JIM340658.

Distribution Pattern:

Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated