Recall Z-2344-2018 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
Ortho-Clinical Diagnostics
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
| Date | May 9, 2018 |
| Status | Terminated |
| Reason | There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples. |
| Root cause | Under Investigation by firm |
| Action | Urgent Product Correction Notification letters were distributed on 5/9/18. The letters instruct customers to do the following: " Immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. " Complete the Confirmation of Receipt form no later than May 23, 2018. Ortho will replace your remaining inventory of the affected lots or credit your account. " Post this notification by each VITROS System in your facility or with the user documentation. " Forward this notification if the product was distributed outside of your facility. If the custo |
| Quantity | 5712 |
| Distribution | Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden |
| FDA record | Open on fda.gov |