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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack

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  Class 2 Device Recall Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack see related information
Date Initiated by Firm October 05, 2016
Create Date December 23, 2016
Recall Status1 Terminated 3 on June 19, 2018
Recall Number Z-0903-2017
Recall Event ID 75476
510(K)Number K101921  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators

For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
Code Information Lot / Expiry date: 1) 0700 (18 Oct 2016), 0710 (14 Nov 2016), 0748 (16 Feb 2017, 0758 (06 Mar 2017); 2) 0728 (12 Dec 2016), 0738 (02 Jan 2017), 0768 (10 Apr 2017)
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information Contact Mr. Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho Clinical sent an Urgent Product Correction Notification letter dated October 5, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS Immunodiagnostic Products iPTH to inform them of the issue and the required actions. Foreign affiliates were informed by email on October 5, 2016, of the issue and instructed to notify their customers of the issue and the required actions. Required Actions - Until further notice, be aware of positively biased results when using the device. Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. In accordance with regulatory requirements, complete and return the Confirmation of Receipt form via email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. Customers with questions can call the Ortho Care Technical Solutions Center at 1-800-421-3311. For further questions regarding this recall, please call (585) 453-3452.
Quantity in Commerce 7,027 Total units
Distribution Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
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 = CEW and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
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