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U.S. Department of Health and Human Services

Class 2 Device Recall enGen(TM) Laboratory Automation System

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  Class 2 Device Recall enGen(TM) Laboratory Automation System see related information
Date Initiated by Firm March 17, 2016
Create Date April 26, 2016
Recall Status1 Terminated 3 on May 30, 2018
Recall Number Z-1569-2016
Recall Event ID 73616
510(K)Number K063144  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.
Code Information US Serial Numbers: JFBX395J, GBX395J, J953252, JJXBQW4J, J3RHC23J, J86PWC5J, J5LQ6Q2J, JFCM073J, J54FC01J, J5J4B45J, J7KSC15J, J4HX7S4J, JGWXQ52J, J953221, JG7BFB5J, JHPKG25J, JCXL941J, J736BM4J, JFXCBG3J; -- Foreign Serial Numbers: J89133 (VAS), JHWJZY4J, J3J4B45J, J953244, JCT20Q3J, J16XQH4J, GWJVY4J, DWX052J,  J271264, J271368, J271371, J271269, J85206, J953216, DP2LF62, J7023874, J7023847, J7025017, J7024893, J7023645, J7023435, J57663, J800103, S/N 89VQ762 (VAS), J75863, J75691, J30372, J3055503, J3055496.   
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
FDA Determined
Cause 2
Component design/selection
Action On 3/17/2016 URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2016-074, dated 3/17/2016)) was sent notifying the users of the issue and advise them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Foreign affiliates were informed by email on 3/17/2016 of the issue and instructed to notify their consignees of the issue and required actions.
Quantity in Commerce US: 19, Foreign: 30
Distribution Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.
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 and Original Applicant = Ortho-Clinical Diagnostics, Inc.