Device product
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 (spectrophotometric and spectrophotometric immunoassay methods.) 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).
Z-2140-2014
Product summary
- Event
- Event 68790
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 81, Foreign: 238
- Official record key
device-enforcement:Z-2140-2014
Official wording
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.
Code information: Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers, for VITROS 4600 systems the J Numbers start with 4600XXXX)
Distribution pattern: 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.
Derived failure modes
-
Device software or design
anomaly with VITROS System Software