Recall Z-1227-2023— Aniara Diagnostica LLC

Name: FDA recall Z-1227-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-01

Class II · Ongoing

Class II FDA medical device recall by Aniara Diagnostica LLC, initiated 2023-02-01. It names one FDA 510(k) clearance: K050365. 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: 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.

Recalling firm: Aniara Diagnostica LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-02-01
Firm location: West Chester, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202Hyphen Biomed·cleared 2005-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.