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U.S. Department of Health and Human Services

Class 3 Device Recall ULTRACRP

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  Class 3 Device Recall ULTRACRP see related information
Date Initiated by Firm December 03, 2003
Date Posted January 06, 2004
Recall Status1 Terminated 3 on April 20, 2005
Recall Number Z-0295-04
Recall Event ID 27874
510(K)Number K001009  
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
Product POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only.

COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.



Code Information Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04)
Recalling Firm/
Manufacturer		 Polymedco, Inc
510 Furnace Dock Road
Cortlandt Manor NY 10567-6220
For Additional Information Contact Ms. Helen Landicho
914-739-5400
Manufacturer Reason
for Recall		 Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
FDA Determined
Cause 2		 Other
Action By phone on 12/3/03 and by mail on 12/5/03.
Quantity in Commerce 165 Kits
Distribution Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
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 = DCK and Original Applicant = RANDOX LABORATORIES, LTD.
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