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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products PHYT Slides

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 Class 2 Device Recall VITROS Chemistry Products PHYT Slidessee related information
Date Initiated by FirmAugust 20, 2014
Date PostedOctober 02, 2014
Recall Status1 Terminated 3 on April 11, 2017
Recall NumberZ-0007-2015
Recall Event ID 69094
510(K)NumberK941142 
Product Classification Enzyme immunoassay, diphenylhydantoin - Product Code DIP
ProductVITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information Lot Number 2613-0150-4913, exp. 15-Nov-2014
FEI Number 1000305840
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn 8/20/14, an URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-222, dated 8/20/14) was sent via FedEx overnight courier and/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. One foreign affiliate was notified on 8/20/14. One distributor was notified on 8/20/14. The customers were advised to: - Immediately discontinue using and discard VITROS Chemistry Products PHYT slide Lot 2613-0150-4913. Review VITROS PHYT results obtained using Lot 2613-0150-4913 and discuss any concerns they may have regarding previously reported results with their Laboratory Medical Director or with the requesting physician. Complete the attached Confirmation of Receipt form no later than 8/28/14. Forward the information in this notification if they have distributed this product outside of their facility facility.
Quantity in CommerceDomestic: 339 sales units; Foreign: 10 sales units
DistributionDistributed USA (nationwide) and in Singapore.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DIP
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