Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Recommended Action

Per FDA guidance

Update 12/15/22: Ortho Clinical Issued Further Corrective Action: Resolution To Potential For Negative Bias When Using Vitros Immunodiagnostic Products Intact Pth Reagent Pack. Letter states: Beginning with Lot 1676 (and subsequent lots), VITROS iPTH Reagent Pack has undergone a performance change in the math associated with the internal master calibration to remove the negative bias observed in previous affected lots. This change brings the performance of VITROS iPTH Reagent Pack back to expected levels. The next lot of VITROS Immunodiagnostic Products iPTH Controls to support this change will be Lot 1090. Please note that Lots 1676 and above of iPTH Reagent Pack will only be supported by Lots 1090 and above of VITROS iPTH Controls. Beginning with Lot 1676 (and subsequent lots) of VITROS iPTH Reagent Pack, customers will no longer be required to adjust their laboratory s reference interval when performing patient sample testing. When using VITROS iPTH Reagent Pack intraoperatively, any unaffected lot may once again be used for patient sample testing. To maintain the expected performance of this product, after switching to Lot 1676 (and subsequent lots) customers are advised not to switch back to any of the previous affected lots of VITROS iPTH Reagent Pack. Ortho has also provided new control values for the non-Ortho controls listed beginning on page 2. " Please note that these new control values are available for use with Lots 1676 and above only. " The non-Ortho control values provided in the previous communication (Ref. CL2022-275) are acceptable for use with VITROS iPTH Reagent Pack Lots 1610, 1621, 1630, 1640, 1645, 1650, and 1670. " The original non-Ortho control values, assigned during release, are acceptable for use with Lot 1660 and Lots prior to 1610. " New control lots will be suitable for use with Lot 1676 and above only. The new lots of VITROS iPTH Reagent Pack and VITROS iPTH Controls are available now. To ensure product availability, Ortho has impl