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U.S. Department of Health and Human Services

Class 2 Device Recall Vitros Chemistry Products PHYT Slide

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  Class 2 Device Recall Vitros Chemistry Products PHYT Slide see related information
Date Initiated by Firm May 09, 2018
Create Date July 03, 2018
Recall Status1 Terminated 3 on August 18, 2020
Recall Number Z-2344-2018
Recall Event ID 80163
510(K)Number K941142  K081543  
Product Classification Enzyme immunoassay, diphenylhydantoin - Product Code DIP
Product VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Code Information 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
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DIP and Original Applicant = EASTMAN KODAK COMPANY
510(K)s with Product Code = DIP and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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