Reported Jun 17, 2015 · Terminated
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with
- all of the following system componentsRecapper 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 NAMEenGen 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
- Lot codes and dates
- Serial Numbers
J89134JIM341226341516JIM342964JIM340432JIM340814IM341243JIM336912J271265J271369J271372J271267J85208JIM342217J7023890J7023841J7025007J7024894J7023648J7021530J57662J8006290J75685J30370J3055510J3055507JIM341820JIM341679JIM341174JIM340667JIM-341592JIM336957JIM341477JIM336855JIM334236JIM341415JIM341392JIM340934JIM336167JIM342249JIM341750JIM341426JIM334527JIM341021JIM340658
- Serial Numbers
- Amount recalled
- 45 units worldwide (Domestic: 19 units, Foreign: 26)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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