# FDA recall Z-1227-2023

> **Aniara Diagnostica LLC** · Class II · device recall initiated 2023-02-01.

## Product

BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.

## Reason for recall

New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility

## Distribution

US Nationwide distribution in the state of NC.

## Key facts

- **Recall number:** Z-1227-2023
- **Recalling firm:** Aniara Diagnostica LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-01
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1227-2023

## Citation

> AI Analytics. FDA recall Z-1227-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1227-2023. Source: US FDA. Licensed CC0.

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