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U.S. Department of Health and Human Services

Class 2 Device Recall enGen Laboratory Automation System

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  Class 2 Device Recall enGen Laboratory Automation System see related information
Date Initiated by Firm April 06, 2015
Date Posted June 08, 2015
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-1729-2015
Recall Event ID 70918
510(K)Number K063144  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Assay Data Disk (ADD), All DRV versions that support product within expiry dating

Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing
Code Information Product Code: 6801876 Unique Device Identifier Numbers: 10758750001576
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall
Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
FDA Determined
Cause 2
Software design
Action Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1- 800-421-3311 anytime.
Quantity in Commerce 2,387 units Total (987 domestically & 1400 internationally)
Distribution Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
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.