ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
- Recall Initiated
- March 9, 2020
- Terminated
- February 11, 2021
- Recall Number
- Z-1728-2020
- Quantity
- 7,347 kits
Reason for Recall
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Distribution
US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
Lot / Code Info
List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.
Root Cause
Mixed-up of materials/components
Action Taken
Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.