VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

On 7/07/2014, Customer Letter (Ref. CL2014-191) was 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) to inform them of the issue and advise them of the required actions. On 7/07/2014, Distributor Letter (Ref. DL2014-191 was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees instructing them to notify their consignees of the issue and required actions. Foreign affiliates were informed by e-mail on 7/07/2014 of the issue and instructed them to notify their consignees of the issue and required actions. For questions, please contact Customer Technical Services at 1-800-421-3311.