Recall Z-2879-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho Clinical Diagnostics
VITROS XT7600 Integrated System, Product code 6844461
| Date | Jul 20, 2020 |
| Status | Terminated |
| Reason | When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. |
| Root cause | Process control |
| Action | The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected |
| Quantity | pending |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, 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 |