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U.S. Department of Health and Human Services

Class 3 Device Recall BIOPHEN UFH Control plasma

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  Class 3 Device Recall BIOPHEN UFH Control plasma see related information
Date Initiated by Firm June 28, 2022
Create Date September 15, 2022
Recall Status1 Terminated 3 on April 18, 2024
Recall Number Z-1743-2022
Recall Event ID 90765
510(K)Number K051472  
Product Classification Plasma, coagulation control - Product Code GGN
Product BIOPHEN UFH Control Plasma
Code Information UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information Contact
513-770-1993
Manufacturer Reason
for Recall		 Incorrect product labeling was included in the package.
FDA Determined
Cause 2		 Under Investigation by firm
Action A recall notification letter was issued on August 3, 2022 to impacted consignees. Consignees were informed that the product is packaged with the incorrect insert ("flyer"). The recalling firm instructs consignees to destroy the included incorrect insert and use the attached correct insert. An Awareness Acknowledgement Form should be completed and returned to the recalling firm acknowledging that the information was received and the incorrect inserts were destroyed.
Quantity in Commerce 13 units (1 unit is 1 box)
Distribution Distribution in US - IL and MI
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GGN and Original Applicant = HYPHEN BIOMED
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