VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
FDA Recall Z-2344-2018 · Posted None
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDIP
Date Initiated2018-05-09
Date Terminated2020-08-18
Product Quantity5712
Reason for Recall
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.
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 customer is a distributor, they were also instructed to:
" Send the letter to all customers who were shipped an affected lot of VITROS PHYT Slides.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.