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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS 3600

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 Class 3 Recall
VITROS 3600
see related information
Date Posted February 21, 2012
Recall Status1 Open
Recall Number Z-1072-2012
Recall Event ID 60881
Premarket Notification
510(K) Number
K083173 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product VITROS® 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS® 3600 --- NOTE: VITROS® 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS® Immunodiagnostic Products Reagents.
Code Information All VITROS¿ 3600 Systems Catalog # 6802783 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 36000206, 36000268, 36000269, 36000290, 36000319, 36000404, 36000414, 36000416, 36000426, 36000430, 36000453, 36000464, 36000466, 36000467, 36000475, 36000143, 36000151, 36000152, 36000159, 36000165, 36000187, 36000194, 36000198, 36000204, 36000222, 36000228, 36000257, 36000258, 36000271, 36000275, 36000279, 36000301, 36000306, 36000307, 36000313, 36000315, 36000322, 36000324, 36000325, 36000326, 36000327, 36000330, 36000332, 36000333, 36000335, 36000336, 36000338, 36000342, 36000347, 36000348, 36000352, 36000353, 36000355, 36000360, 36000364, 36000365, 36000372, 36000374, 36000382, 36000384, 36000389, 36000390, 36000391, 36000392, 36000394, 36000395, 36000400, 36000401, 36000403, 36000405, 36000408, 36000421, 36000422, 36000425, 36000429, 36000431, 36000434, 36000438, 36000441, 36000442, 36000443, 36000448, 36000461, 36000462, 36000468, 36000469, 36000470, 36000471, 36000472, 36000473, 36000476, 36000477, 36000478, 36000479, 36000481, 36000483. -- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue.
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester, New York 14626
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Carol Montandon
908-218-8190
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development Assay Data Disk (ADD) that was available in the on-screen mailbox on the Main Menu System Status screen of their VITROS¿ 5600 Integrated System. OCD's investigation determined that ADD, Data Release Version (DRV) 9241 or 9251 was electronically transferr
FDA Determined
Cause 2
DESIGN: Software Design
Action Ortho-Clinical Diagnostics (OCD) sent an Important Product Correction Notification letters dated April 13, 2011 via FedEx overnight to customers with an affected VITROS® 3600 or 5600 System (those not e-Connected). Foreign affiliate consignees were informed of this action via e-mail on April 13, 2011. The letters described the affected products, problem and actions to be followed. The letters states that an OCD Field Engineer will contact customers who has the affected products and perform a Modification (MOD) procedure that will remove ADD DRV 9241 or 9251 from the on-screen mailbox of their system(s). Customers were instructed to complete and return the accompanying Confirmation of Receipt Form and fax to1-888-557-3759 or 1-585-453-4110. The letter asks that distributors forward a copy of the enclosed customer communication to all customers who were shipped an affected VITROS® 3600 or 5600 System. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.
Quantity in Commerce Domestic - 15 units, foreign - 81 units
Distribution Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.
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
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