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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 5see related information
Date Initiated by FirmFebruary 01, 2023
Date PostedMarch 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1227-2023
Recall Event ID 91618
510(K)NumberK050365 
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
ProductBIOPHEN 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)
FEI Number 3005017664
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information ContactSAME
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
ActionAniara 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 Commerce2 units
DistributionUS Nationwide distribution in the state of NC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GGP
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