Recall Z-1854-2025— Mckesson Medical-Surgical Inc. Corporate Office
Class II · Ongoing
Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2025-04-24. FDA's recall record names no specific 510(k) clearance for this event. Product: SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.. Reason: 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..
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-24
- Firm location
- Richmond, VA, United States
Product description
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.