Class 2 Device Recall STA Neoplastine Cl

• Date Initiated by Firm: October 25, 2017
• Create Date: March 15, 2018
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-1068-2018
• Recall Event ID: 79292
• 510(K)Number: K922565
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
• Code Information: Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Donald Kraft; 973-631-1200
• Manufacturer Reason for Recall: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
• FDA Determined Cause: Device Design
• Action: Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).
• Distribution: Nationally
• 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 = GJS