ARCHITECT HAVAB G Reagent Kit — Class II medical device recall Z-1728-2020
Terminated recall by Abbott Gmbh & Co. KG, reported 2020-04-29, distributed nationwide. An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased
| Recall number | Z-1728-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany |
| Recall initiated | 2020-03-09 |
| Classified | 2020-04-17 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 7,347 kits |
| Reason classes | microbial contamination |
| Pathogens | hepatitis a |
| UPC / GTIN / UDI-DI | 00380740011185 |
| Lot numbers | 03429BE00, 06172BE00, 08073BE00, 10353BE00 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1728-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.