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U.S. Department of Health and Human Services

Class 2 Device Recall BIOPHEN" Protein C 5

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  Class 2 Device Recall BIOPHEN" Protein C 5 see related information
Date Initiated by Firm February 01, 2023
Date Posted March 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1227-2023
Recall Event ID 91618
510(K)Number K050365  
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
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.
Code Information UDI-DI: 366353700063BD Lot FA083327 (And all future lots)
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information Contact SAME
513-770-1993
Manufacturer 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 2		 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 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.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the state of NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GGP and Original Applicant = HYPHEN BIOMED
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