Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

FDA Recall Z-1854-2025 · Posted 2025-05-27

Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Recall StatusOpen, Classified
Product CodeJJX
Date Initiated2025-04-24
Product Quantity1 unit

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.

Firm Action

An URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to [email protected] and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers.

Root Cause

Storage

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑