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.
FDA Recall Z-2352-2016 · Posted None
Recalling FirmORTHO-CLINICAL DIAGNOSTICS
Recall StatusTerminated
Product CodeCHP
Date Initiated2016-07-14
Date Terminated2018-06-08
Product QuantityDomestic: 1620; Foreign: 7597
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.