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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 5600 Integrated System

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 Class 2 Recall
VITROS 5600 Integrated System
see related information
Date Posted June 01, 2012
Recall Status1 Open
Recall Number Z-1699-2012
Recall Event ID 61790
Premarket Notification
510(K) Number
K081543 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Code Information Product code: 6802413; Serial numbers: 56000118 - 56001498
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
1000 Lee Road
Rochester, New York 14606
Consumer Instructions No consumer action necessary
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
FDA Determined
Cause 2
DESIGN: Software Design
Action Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated April 26, 2012, via FedEx overnight courier to US consignees with VITROS® 5600 Systems. The letter identified the affected product, problem and actions to be taken. Foreign affiliates were informed by email on April 26, 2012 of the issue and instructed to notify their consignees of the issue and actions. OCD recommend customers to group all DAT assays into a single run as described in the letter, until the next Software Version 2.0 is installed on their VITROS® 5600 System. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.
Quantity in Commerce 1357 units
Distribution Worldwide Distribution - US (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS, INC.
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