Recall Z-0878-2023 ยท CEW Radioimmunoassay, Parathyroid Hormone
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
| Date | Jan 4, 2023 (initiated Nov 17, 2022) |
| Status | Open, Classified |
| Reason | Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results |
| Root cause | Under Investigation by firm |
| Action | 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 wi |
| Quantity | 4,158 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom. |
| 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 |