Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its VITROS 25-OH Vitamin D Total Calibrators [Product Code: 6842893; Lot numbers: 0091 through 0235].
The manufacturer has found that the VITROS Immunodiagnostic Product 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results
The manufacturer advises all affected users to immediately discard all current lots of VITROS Immunodiagnostic Product 25-OH Vitamin D Total Calibrators and Reagent Packs (Lots 0200, 0210, 0220, 0230 and 0235). Affected users are also instructed to review previously reported results generated using VITROS Immunodiagnostic Product 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 January 2014