Recall Z-0641-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. 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 Reagen
| Date | Jan 13, 2016 (initiated Nov 3, 2015) |
| Status | Terminated |
| Reason | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results. |
| Root cause | Software design |
| Action | Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-211, dated November 3, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 3600 and 5600 Systems). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/03/2015 of the issue and instructed to notify their consignees of the issue and required actions. Ortho |
| Quantity | Domestic: 1083, Foreign: 999 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, T |
| 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 |