PlainRecalls
FDA Devices Moderate Class II Ongoing

ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.

Reported: June 4, 2025 Initiated: April 24, 2025 #Z-1842-2025

Product Description

ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.

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.

Details

Units Affected
4 units
Distribution
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 4 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1842-2025.