Class 2 Device Recall Pointe Scientific

• Date Initiated by Firm: June 09, 2006
• Date Posted: September 30, 2006
• Recall Status: Terminated on November 20, 2007
• Recall Number: Z-1549-06
• Recall Event ID: 35499
• 510(K)Number: K882117
• Product Classification: Alcohol assay - Product Code JIX
• Product: Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD.
• Code Information: Lot 509102; exp. 9/06.
• Recalling Firm/ Manufacturer: Pointe Scientific, Inc.; 5449 Research Dr; Canton MI 48188-2261
• For Additional Information Contact: 734-487-8300
• Manufacturer Reason for Recall: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
• Quantity in Commerce: 44 units
• Distribution: Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
• 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 = JIX