Recall Z-1222-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Re
| Date | Mar 11, 2019 |
| Status | Terminated |
| Reason | One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user. |
| Root cause | Software design |
| Action | Urgent Product Correction Notification letters dated 3/11/19 were sent to customers. |
| Quantity | 80 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VIT Ortho-Clinical Diagnostics, Inc., Oct 30, 2018 |