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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid ALT

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  Class 2 Device Recall Liquid ALT see related information
Date Initiated by Firm December 14, 2007
Date Posted May 22, 2008
Recall Status1 Terminated 3 on September 15, 2008
Recall Number Z-1110-2008
Recall Event ID 45909
510(K)Number K941287  
Product Classification in vitro diagnostic - Product Code CKA
Product Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
Code Information Lots 628302-005, 628302-059, 628302-085, 628302-086, 628302-087, 704601-087, 704601-130, 704601-131, 704601-134 and 704601-191.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-757-5313
Manufacturer Reason
for Recall		 Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
FDA Determined
Cause 2		 Process control
Action Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.
Quantity in Commerce 955 for all products.
Distribution Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and 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 = CKA and Original Applicant = POINTE SCIENTIFIC, INC.
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