FDAFDA · Food and drugs·Recall number Z-1854-2025
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Published June 4, 2025 · Recall initiated: April 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- Lot
- Catalog No. 138; GTIN: 742860100093; Order No. 45402895.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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