enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- C
FDA device recall Z-0914-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.
- Action taken
- Ortho-Clinical Diagnostics sent an Urgent Product Correction Notification letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to post the enclosed attachment near their centrifuge as a reference. Clean and carefully inspect the suspension groove area of the centrifuge buckets for cracks as part of their weekly maintenance procedure. Careful to check for micro-cracks that may not be easily detectable. If any cracks/micro-cracks, corrosion or damage are present, they must immediately discontinue using the centrifuge and contact OCD Customer Technical Services at 1-800-421-3311 to obtain replacements. OCD recommends that they do not exceed the manufacturer's relative centrifuge force (RCF) and run time limits for the blood collection devices used by their laboratory. Complete and return the attached Confirmation of Receipt Form. For questions regarding this recall call the Customer Service Center at 1-800-421-3311. .
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 78 units worldwide (18 Domestic and 68 Foreign)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.
- Date initiated
- 2011-04-28
- Date posted
- 2012-01-26
- Date terminated
- 2018-07-02
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144) | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |