Aniara Diagnostica LLC: Medical Device Recall in 2023 - (Recall #: Z-1227-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 1, 2023

Date Posted: March 15, 2023

Recall Number: Z-1227-2023

Event ID: 91618

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

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI-DI: 366353700063BD Lot FA083327 (And all future lots)

Distribution Pattern:

US Nationwide distribution in the state of NC.

Voluntary or Mandated:

Voluntary: Firm initiated