Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Aniara Diagnostica
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
Incorrect product labeling was included in the package.
Residual crystallization of the microplate and recurrent negative controls out of range.
Residual crystallization of the microplate and recurrent negative controls out of range.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.