Recall Z-2140-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectropho
| Date | Aug 1, 2014 (initiated Jul 7, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | 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 7/07/20 |
| Quantity | Domestic: 81, Foreign: 238 |
| 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. |
| FDA record | Open on fda.gov |