Aniara Diagnostica LLC: Medical Device Recalls in 2023

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Aniara Diagnostica LLC in 2023. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

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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.