Ortho-Clinical Diagnostics, Inc. is recalling 481 units of VITROS Immunodiagnostic Products Anti HBs Calibrators due to signal reduction over the product's shelf life. This defect can lead to positively biased test results, meaning a patient's test might incorrectly indicate a higher level of Hepatitis B antibodies than actually present. The recall includes calibrator packs containing three color-coded tubes (green, yellow, and red) from lots 9010 and 9030.
The signal reduction in these calibrators causes the diagnostic system to produce inaccurate, elevated readings. This could lead to incorrect medical assessments of a patient's immunity or response to Hepatitis B vaccination.
Consultation and manufacturer contact
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Sources: FDA iRES · Raw API Response
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