Recall Z-1004-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
| Date | Jan 20, 2015 (initiated Sep 29, 2014) |
| Status | Terminated |
| Reason | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated September 29, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. The resolution to this software anomaly will be in a future version of software. Until the new software is installed on their VITROS System, customers were instructed not to use the calibrator barcode labels for VITROS Cal |
| Quantity | 12 units |
| Distribution | Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain. |
| FDA record | Open on fda.gov |