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U.S. Department of Health and Human Services

Class 3 Device Recall BIOPHEN LMWH Control C4

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  Class 3 Device Recall BIOPHEN LMWH Control C4 see related information
Date Initiated by Firm March 19, 2019
Create Date April 17, 2019
Recall Status1 Terminated 3 on July 12, 2019
Recall Number Z-1190-2019
Recall Event ID 82468
510(K)Number K051472  
Product Classification Plasma, coagulation control - Product Code GGN
Product BIOPHEN LMWH Control C4, REF 224201
Code Information Lots F1701555P4
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information Contact Colleen Murphy
513-770-1993
Manufacturer Reason
for Recall		 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
FDA Determined
Cause 2		 Error in labeling
Action On March 18, 2019, the recalling firm notified its two affected customers of the recall via email. The email included an attached Urgent Medical Device Correction letter from HYPHEN BioMed, which informed customers that incorrect instructions for use had been packaged into specific lots of three device product codes. Customers were instructed to destroy the incorrect IFUs and begin using the corrected IFUs. Customers were also asked to complete and return customer response forms to Aniara Diagnostica.
Quantity in Commerce 3 units
Distribution Distributed to accounts in MI and PA.
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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