Z-2352-2016Class II

VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017...

Name: Z-2352-2016 VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017...
Creator: Ortho-Clinical Diagnostics
Published: 2016-07-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-07-14 / Terminated / root cause: design

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD --... on 2016-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2352-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-08-05
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: CHP Radioimmunoassay, Estradiol
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2352-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2352-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05

Product code CHP

K970643Class IVitros Immunodiagnostics Products Estradiol Reagent Pack(gem. 1050)/Estradiol Calibrators (Gem.c050)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1997-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)