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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Alk Phos R1

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  Class 2 Device Recall Liquid Alk Phos R1 see related information
Date Initiated by Firm June 09, 2006
Date Posted August 10, 2006
Recall Status1 Terminated 3 on November 19, 2007
Recall Number Z-1394-06
Recall Event ID 35496
510(K)Number K973588  
Product Classification in vitro diagnostic - Product Code CJE
Product Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro diagnostic.
Code Information Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
800-445-9853 Ext. 110
Manufacturer Reason
for Recall		 The reagent may be contaminated with microorganisms.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 6/9/06 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 890 L total, all products
Distribution Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
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.
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