Z-1850-2025 Class II Ongoing
FDA device recall Z-1850-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on April 24, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- April 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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 Pattern
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Code Information
Catalog No. 07K6502; GTIN: 380740081034; Order No. 46048552.