# FDA recall Z-0045-2020

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2017-07-21.

## Product

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use.  The firm name on the label is Helena Laboratories, Beaumont, TX.

## Reason for recall

The plates do not have wells punched for the controls in the patient 1 area.

## Distribution

Distribution was made to IN, KY,  MA, OH, OR, TN, and TX.  There was government distribution.  Foreign distribution was made to Chile.

## Key facts

- **Recall number:** Z-0045-2020
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2019-10-16
- **Termination date:** 2020-06-19

- **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-0045-2020

## Citation

> AI Analytics. FDA recall Z-0045-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0045-2020. Source: US FDA. Licensed CC0.

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