# FDA recall Z-1479-2024

> **Abbott GmbH** · Class II · device recall initiated 2024-03-04.

## Product

ARCHITECT Anti-HCV Reagent Kit, List Numbers:  a) 1L79-25, b) 1L79-35

## Reason for recall

Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument:  " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79).  " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1479-2024
- **Recalling firm:** Abbott GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-04
- **Report date:** 2024-04-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2024

## Citation

> AI Analytics. FDA recall Z-1479-2024. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1479-2024. Source: US FDA. Licensed CC0.

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