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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 ULTRACRPsee related information
Date Initiated by FirmDecember 03, 2003
Date PostedJanuary 06, 2004
Recall Status1 Terminated 3 on April 20, 2005
Recall NumberZ-0296-04
Recall Event ID 27874
510(K)NumberK001009 
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
ProductPOLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). 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 1155J (EXP. 09/04) and 1388J (EXP. 10/04)
FEI Number 1000119795
Recalling Firm/
Manufacturer		 Polymedco, Inc
510 Furnace Dock Road
Cortlandt Manor NY 10567-6220
For Additional Information ContactMs. 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
ActionBy phone on 12/3/03 and by mail on 12/5/03.
Quantity in Commerce584 Kits
DistributionMedical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DCK
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