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Class 2 Device Recall VITROS 5,1 FS Chemistry System |
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Date Initiated by Firm |
September 10, 2015 |
Date Posted |
November 05, 2015 |
Recall Status1 |
Terminated 3 on May 29, 2018 |
Recall Number |
Z-0231-2016 |
Recall Event ID |
72220 |
510(K)Number |
K031924 K063144
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Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product |
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest. |
Code Information |
Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897. |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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Manufacturer Reason for Recall |
Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.
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FDA Determined Cause 2 |
Software design |
Action |
The firm, Ortho Clinical Diagnostics, sent a "FOLLOW UP to URGENT PRODUCT CORRECTION NOTIFICATION" letter dated 9/10/2015 and response forms to customers via FedEx overnight courier, e-mail (ORTHO PLUS e-Communications) and/or via US Postal Service overnight letter on 9/10/2015. Foreign affiliates were informed by email on 9/10/2015 of the issue and instructed to notify their consignees of the issue and required actions.
The letter described the product, problem, and actions to be taken. The customers were instructed to follow the required actions and complete and return the Confirmation of Receipt-Response Required form, no later
than 9/18/15, by fax at 1.888.557.3759 or 1.585.453.4110, or scan PDF and email to: ConfirmationAdmin@its.jnj.com. Customers with any additional questions, can contact Customer Technical Services at 1-800-421-3311 at any time. |
Quantity in Commerce |
Catalog # 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147 |
Distribution |
Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS 510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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