FDA recall Z-1850-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-04-24
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2025