Reported Mar 15, 2023 · Ongoing
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma.…
Aniara Diagnostica LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aniara Diagnostica LLC · 7768 Service Center Dr · West Chester, OH · 45069-2442
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI366353700063BD Lot FA083327 (And all future lots)
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- NC
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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