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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-1111-2008
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, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
Code Information Lots 628302-023, 628302-024, 628302-025, 628302-067, 628302-068, 704601-068, 704601-107, 704601-108, 704601-109, 704601-134 and 704601-166.
Recalling Firm/
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
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.