Recall Z-1348-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
| Date | Feb 16, 2016 |
| Status | Terminated |
| Reason | The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged. |
| Root cause | Process control |
| Action | On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user do |
| Quantity | 2,101 Total units (1,043 domestically & 1,058 internationally) |
| Distribution | Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc., Oct 23, 2008 |