FDA Device recall Z-1728-2020
ARCHITECT HAVAB G Reagent Kit
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of ARCHITECT HAVAB G Reagent Kit by Abbott And Kg, citing an erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1728-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-09 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
Product
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Reason
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Identifiers
| code_info | List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1728-2020%22
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