ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Check against the official notice below — it lists the full affected range.
Abbott GmbH & Co. KG is recalling the ARCHITECT HAVAB G Reagent Kit (List Number 6L27 25) due to an error during manufacturing. An incorrect concentration value for hepatitis A virus was used during production, which resulted in a lower amount of antigen in the affected kits than intended. A total of 7,347 kits were distributed nationwide across all U.S. states and Puerto Rico.
The recall affects four specific lot numbers: 03429BE00, 06172BE00, 08073BE00, and 10353BE00. Consumers or healthcare facilities with these kits can identify them using the provided UDI (Unique Device Identifier) codes. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
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. Quantity: 7,347 kits 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.