Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIOPHEN Protein C 5 kit is for in vitro quantitative Recalled by Aniara Diagnostica LLC Due to New warnings and precautionary statements on product labelling:...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aniara Diagnostica LLC directly.
Affected Products
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.
Quantity: 2 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aniara Diagnostica LLC
Aniara Diagnostica LLC has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report