Recall Z-2352-2016 ยท CHP Radioimmunoassay, Estradiol
ORTHO-CLINICAL DIAGNOSTICS
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 VITRO
| Date | Jul 14, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) Johnson & Johnson Clinical Diagnostics, Inc., Mar 18, 1997 |