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U.S. Department of Health and Human Services

Class 3 Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT

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  Class 3 Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT see related information
Date Initiated by Firm February 02, 2009
Date Posted April 17, 2009
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1202-2009
Recall Event ID 51042
510(K)Number K040391  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
Product Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI.

The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
Code Information HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-757-5313
Manufacturer Reason
for Recall		 The product performance fails due to precipitation of the R2 component.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in Commerce 24 kits
Distribution Worldwide Distribution -- USA, Chile and Mexico.
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 = CIG and Original Applicant = POINTE SCIENTIFIC, INC.
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