Class 2 Device Recall VITROS Immunodiagnostic Products Estradiol Reagent Pack

• Date Initiated by Firm: July 14, 2016
• Create Date: August 05, 2016
• Recall Status: Terminated on June 08, 2018
• Recall Number: Z-2352-2016
• Recall Event ID: 74764
• 510(K)Number: K970643
• Product Classification: Radioimmunoassay, estradiol - Product Code CHP
• Product: VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
• Code Information: Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)
• Recalling Firm/ Manufacturer: ORTHO-CLINICAL DIAGNOSTICS; FELINDRE MEADOWS; Bridgend United Kingdom
• For Additional Information Contact: Ms. Jennifer Paine ; 908-218-8776
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant.
• FDA Determined Cause: Device Design
• Action: On 7/14/2016, URGENT PRODUCT CORRECTION NOTIFICATION Customer Letter (Ref. CL2016-141, dated 7/14/2016) was sent 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 product since 6/1/2015 to inform them that Fulvestrant is an interferent of the Estradiol Reagent Pack and causes positively biased results. Discuss any concerns you may have regarding previously reported estradiol results with your Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. For questions, contact Customer Technical Services at 1-800-421-3311. Foreign affiliates were informed of the issue via e-mail on 7/14/2016 and instructed to notify their consignees of the issue.
• Quantity in Commerce: Domestic: 1620; Foreign: 7597
• Distribution: Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.
• 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 = CHP