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

Hazard

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

Details from the source

Reason for recall: Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results 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. Quantity: 4,158 units Lot/code info: UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610 24-Apr-2023; 1621 24-Apr-2023; 1630 08-May-2023; 1640 08-May-2023; 1645 08-May-2023; 1650 29-May-2023; 1670 06-Jun-2023

UPC codes

10758750006267

Source

Official record: FDA (Device enforcement) ↗

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