Recall Z-1075-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both
| Date | Mar 8, 2016 (initiated Dec 21, 2015) |
| Status | Terminated |
| Reason | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall). |
| Root cause | Error in labeling |
| Action | Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 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). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be ta |
| Quantity | US = 994; Foreign = 1405 |
| Distribution | Worldwide Distribution - US 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 |
| FDA record | Open on fda.gov |