# FDA recall Z-1728-2020

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2020-03-09.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1728-2020
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-09
- **Report date:** 2020-04-29
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2020

## Citation

> AI Analytics. FDA recall Z-1728-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1728-2020. Source: US FDA. Licensed CC0.

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