Recall Z-0903-2017 ยท CEW Radioimmunoassay, Parathyroid Hormone
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
| Date | Oct 5, 2016 |
| Status | Terminated |
| 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 res |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT Ortho-Clinical Diagnostics, Oct 22, 2010 |