Recall Z-1847-2025

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

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

Codes / lots: Catalog No. 04P5325; GTIN: 380740007775; Order No. 46061983.

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.

FDA-determined cause: Storage

Action taken

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.

Details

Recall number
Z-1847-2025
Initiated
April 24, 2025
Posted by FDA
May 27, 2025
Product code
LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Quantity
400 units
Distribution
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA

Official FDA recall record

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