Class II

Medical Device Recall: ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office · April 24, 2025

Reason for Recall

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Distribution

US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

States Affected

NATIONWIDE

Quantity Affected

300 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1833-2025

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.