Z-1728-2020 Class II Terminated
FDA device recall Z-1728-2020 was initiated by Abbott Gmbh & Co. KG on March 9, 2020 and is designated Class II. 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. The recall status is terminated (terminated February 11, 2021). Affected quantity: 7,347 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 9, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,347 kits
Product Description
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
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 Pattern
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.
Code Information
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.