—#164722

Product

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

FDA product code: DIP — Enzyme Immunoassay, Diphenylhydantoin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K081543, K941142
Affected lot / code info: Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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

Timeline

Recall initiated: 2018-05-09
Terminated: 2020-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164722. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.