—#136349

Product

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K063144
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Component change control

Action the firm took

On 5/06/2015, a customer letter (Ref. CL2015-092) with recommendation to prevent this issue was sent to all customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by email to subscribers of ORTHO PLUS e-Communications. Foreign affiliate consignees were notified by e-mail on 5/06/2015 informing them of the issue. For questions, please call Customer Technical Services at 1-800-421-3311 at any time.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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

Timeline

Recall initiated: 2015-05-06
Posted by FDA: 2015-06-08
Terminated: 2018-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.