Class II

Medical Device Recall: VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

Ortho-Clinical Diagnostics, Inc. · March 1, 2024

Reason for Recall

Potential for positively biased results due to signal reduction over shelf life.

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.

States Affected

NATIONWIDE

Quantity Affected

481 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2142-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.