Class 3 Device Recall The Pointe Scientific CKMB Isoenzyme Control

• Date Initiated by Firm: November 22, 2010
• Date Posted: June 29, 2017
• Recall Status: Terminated on July 24, 2017
• Recall Number: Z-2649-2017
• Recall Event ID: 77453
• 510(K)Number: K942958
• Product Classification: U.V. Method, cpk isoenzymes - Product Code JHW
• Product: The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
• Code Information: Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
• Recalling Firm/ Manufacturer: Medtest Holdings, Inc.; 5449 Research Dr; Canton MI 48188-2261
• For Additional Information Contact: Customer Support; 800-445-9853
• Manufacturer Reason for Recall: Incorrect control range in product labeling
• FDA Determined Cause: Employee error
• Action: On 11/22/2010, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
• Quantity in Commerce: 5 kits
• Distribution: FL, AR, NICARAGUA, KOREA
• 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 = JHW