Ortho-Clinical enGen Laboratory Automation System Recalled for Sample Handling Defects
Ortho-Clinical Diagnostics is recalling 45 enGen Laboratory Automation Systems worldwide because recapper caps may fall off or tubes may be dropped, risking bio-hazardous fluid splashing and cross-contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (bio-hazardous fluid splashing and cross-contamination) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 45 units of the enGen Laboratory Automation System (enGen System) worldwide. The recall affects systems configured with specific Recapper Caps, Recapper Modules, Rack Entry/Exit Modules, and Storage Racks. The affected units were distributed in the United States, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
The recall was initiated because recapper caps may fall off or be knocked from sample tubes placed in the storage racks of entry/exit modules. Additionally, the system's gripper may grab a tube at the wrong height and drop it in the Rack Entry/Exit or Rack Exit module. These mechanical failures may result in the splashing of bio-hazardous fluid. Furthermore, sample cross-contamination may occur if an uncapped tube remains in the rack.
The source text does not specify instructions for consumers or healthcare facilities on how to handle the recalled equipment, nor does it report any illnesses or injuries associated with the defect. The recall number is Z-1724-2015.
The recalled product
- 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…
- 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)
- Serial Numbers: J89134
- JIM341226
- 341516
- JIM342964
- JIM340432
- JIM340814
- IM341243
- JIM336912
- J271265
- J271369
- J271372
- J271267
- J85208
- JIM342217
- J7023890
- J7023841
- J7025007
- J7024894
- J7023648
- J7021530
Distribution
Distributed nationwide across the United States.
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