Class 2 Device Recall Liquid ALT

• Date Initiated by Firm: December 14, 2007
• Date Posted: May 22, 2008
• Recall Status: Terminated on September 15, 2008
• Recall Number: Z-1115-2008
• 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, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.
• Code Information: Lots 628302-025, 628302-346 and 704601-108.
• 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: 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