ORTHO-CLINICAL DIAGNOSTICS: 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

Recall number

Z-0903-2017

Recalling firm

ORTHO-CLINICAL DIAGNOSTICS

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

Status

Terminated

Initiated

2016-10-05

Posted

not on file

Terminated

2018-06-19

Reason

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

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: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. 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

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.

Lot, serial or model codes

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)

510(k) numbers

["K101921"]

PMA numbers

not on file

Product code

CEW

Firm FEI

3007111389

Firm city

Bridgend

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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