# FDA recall Z-0529-2019

> **Helena Laboratories, Inc.** · Class III · device recall initiated 2016-11-07.

## Product

Gel Alkaline Phosphatase Isoenzyme Control Kit:    Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE    Gel Alkaline Phosphatase Isoenzyme Control  20mL  001831     Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

## Reason for recall

Due to a customer experiencing complaints on  bone  fraction of assay not being in range.  The complaint: ~12% lower enzyme activity was noted.

## Distribution

Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.

## Key facts

- **Recall number:** Z-0529-2019
- **Recalling firm:** Helena Laboratories, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-11-07
- **Report date:** 2018-12-12
- **Termination date:** 2021-01-15

- **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-0529-2019

## Citation

> AI Analytics. FDA recall Z-0529-2019. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0529-2019. Source: US FDA. Licensed CC0.

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