Recall Z-1227-2023
Aniara Diagnostica LLC · initiated February 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI-DI: 366353700063BD Lot FA083327 (And all future lots)
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
FDA-determined cause: Other
Action taken
Aniara issued Medical Field Correction Letter (FSCA#29) prepared by HYPHEN BioMed and emailed to the customer by Aniara Diagnostica on 2/1/23. Letter states reason for recall, health risk and action to take: New labelling will be implemented on all new lots as follow: x A new pictogram added on reagent and box label: GHS08 x Signal Word: Warning x Hazard Statements: H361f - Suspected of damaging fertility x Precautionary Statements: o P201 : Obtain special instructions before use. o P280 : Wear protective gloves/protective clothing/eye protection/face protection. o P308 + P313 : IF exposed or concerned: Get medical advice/attention. o P405 : Store locked up. o P501 : Dispose of contents/container in consultation with your regional waste disposer x Hazardous ingredients : Cesium chloride The IFU, label and SDS will be updated. Please return completed and signed Form to your distributor.
Details
- Recall number
- Z-1227-2023
- Initiated
- February 1, 2023
- Posted by FDA
- March 6, 2023
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of NC.
- Recalling firm
- Aniara Diagnostica LLC, West Chester, OH