| Class 2 Device Recall VITROS 5600 Integrated System | |
Date Initiated by Firm | September 08, 2014 |
Date Posted | October 16, 2014 |
Recall Status1 |
Terminated 3 on May 21, 2018 |
Recall Number | Z-0078-2015 |
Recall Event ID |
69234 |
510(K)Number | K081543 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | VITROS 5600 Integrated System, System Product Code 6802413.
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 |
Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers) |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
|
For Additional Information Contact | Ms. Jennifer Paine 908-218-8776 |
Manufacturer Reason for Recall | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden). |
FDA Determined Cause 2 | Software design |
Action | On 9/08/14, URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-232, dated 9/8/14) and Confirmation of Receipt Form were sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government only) to inform them of the issue and advise them of the required actions. Foreign affiliates were informed of the issue via e-mail on 9/8/14 and instructed to notify their consignees of the issue and the required actions. |
Quantity in Commerce | USA: 843; Foreign: 945 |
Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela. |
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
|
|
|
|