Class 2 Device Recall Liquid Alkaline Phosphatase Reagent Set

• Date Initiated by Firm: February 07, 2008
• Date Posted: March 27, 2008
• Recall Status: Terminated 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/ Manufacturer: Pointe Scientific, Inc.; 5449 Research Dr; Canton MI 48188
• For Additional Information Contact: 800-757-5313
• Manufacturer Reason for Recall: May be contaminated with microorganisms.
• FDA Determined Cause: Other
• 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