Recall Z-1227-2023 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Aniara Diagnostica LLC
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)
| Date | Mar 6, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Other |
| Action | 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 |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 Hyphen Biomed, Dec 27, 2005 |