Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.

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.

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 MMSQARecalls@McKesson.com 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.

• FDA enforcement recordOfficial FDA database entry for Z-1830-2025
• FDA 510(k) clearance · K171650The device's official FDA premarket clearance record
• FDA device classification · LCPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7470The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mckesson Medical-Surgical Inc. Corporate OfficeSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.