Class 2 Device Recall enGen(TM) Laboratory Automation Systems

• Date Initiated by Firm: April 28, 2011
• Date Posted: January 26, 2012
• Recall Status: Terminated on July 02, 2018
• Recall Number: Z-0914-2012
• Recall Event ID: 60893
• 510(K)Number: K063144
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
• Code Information: All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Drive; Rochester NY 14626
• For Additional Information Contact: Ms. Carol Montandon; 908-218-8190
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: 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. .
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE