# FDA recall Z-1975-2023

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2023-05-02.

## Product

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators.  used in invitro diagnostics

## Reason for recall

Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.

## Distribution

Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

## Key facts

- **Recall number:** Z-1975-2023
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-02
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beaumont, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2023

## Citation

> AI Analytics. FDA recall Z-1975-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1975-2023. Source: US FDA. Licensed CC0.

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