# FDA recall Z-0537-2020

> **Helena Laboratories, Corp.** · Class III · device recall initiated 2018-05-23.

## Product

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

## Reason for recall

Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and  Platelet aggregation Kit, may contain particulate matter or microbial growth.

## Distribution

US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ  OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan

## Key facts

- **Recall number:** Z-0537-2020
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-23
- **Report date:** 2019-12-04

- **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-0537-2020

## Citation

> AI Analytics. FDA recall Z-0537-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0537-2020. Source: US FDA. Licensed CC0.

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