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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Alkaline Phosphatase Reagent Set

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  Class 2 Device Recall Liquid Alkaline Phosphatase Reagent Set see related information
Date Initiated by Firm February 07, 2008
Date Posted March 27, 2008
Recall Status1 Terminated 3 on June 12, 2009
Recall Number Z-1354-2008
Recall Event ID 46783
510(K)Number K973588  
Product Classification Liquid Alkaline Phosphatase Reagent Set - Product Code CJE
Product Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc
Code Information All Lots beginning with 727801; exp. 4/09.
Recalling Firm/
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
Manufacturer Reason
for Recall
May be contaminated with microorganisms.
FDA Determined
Cause 2
Action Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
Quantity in Commerce 7
Distribution Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
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 = CJE and Original Applicant = POINTE SCIENTIFIC, INC.