# FDA recall Z-1297-2023

> **Entopsis , Inc.** · Class II · device recall initiated 2023-02-21.

## Product

PCRopsis Activator: a)  1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

## Reason for recall

Presence of misleading label statements on the product label.

## Distribution

Nationwide and  Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

## Key facts

- **Recall number:** Z-1297-2023
- **Recalling firm:** Entopsis , Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-21
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Medley, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2023

## Citation

> AI Analytics. FDA recall Z-1297-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1297-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*