Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack 의 리콜

Recall

75476

Class 2

Z-0903-2017

2016-10-05

Terminated

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150465

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.

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.