Z-0903-2017Class II

VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892...

Name: Z-0903-2017 VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892...
Creator: Ortho-Clinical Diagnostics
Published: 2016-10-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-10-05 / Terminated / root cause: labeling and UDI

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code... on 2016-10-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0903-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-12-23
Terminated: 2018-06-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: CEW Radioimmunoassay, Parathyroid Hormone
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.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected]. 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0903-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0903-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

Product code CEW

K101921Class IIVitros Immunodiagnostics Products Intact Pth Reagent Pack, Vitros Immunodiagnostics Products Intact Pth Calibrators, VitOrtho-Clinical Diagnostics / cleared 2010-10-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)