BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Prote
FDA device recall Z-1227-2023 · posted 2023-03-06 · Open, Classified
Recall details
- Recalling firm
- Aniara Diagnostica LLC
- 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
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- GGP
- Quantity affected
- 2 units
- Distribution
- US Nationwide distribution in the state of NC.
- Date initiated
- 2023-02-01
- Date posted
- 2023-03-06
- Location
- West Chester, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (K050365) | Hyphen Biomed | 2005-12-27 |