# FDA recall Z-2434-2019

> **Helena Laboratories, Inc.** · Class II · device recall initiated 2016-10-14.

## Product

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

## Reason for recall

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

## Distribution

Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI     OUS:  Australia, Canada, Jordan, and South Korea

## Key facts

- **Recall number:** Z-2434-2019
- **Recalling firm:** Helena Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-10-14
- **Report date:** 2019-09-11
- **Termination date:** 2023-10-12

- **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-2434-2019

## Citation

> AI Analytics. FDA recall Z-2434-2019. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2434-2019. Source: US FDA. Licensed CC0.

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