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U.S. Department of Health and Human Services

Class 2 Device Recall Neoplastine Cl Plus

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  Class 2 Device Recall Neoplastine Cl Plus see related information
Date Initiated by Firm October 25, 2017
Create Date March 15, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1067-2018
Recall Event ID 79292
510(K)Number K922040  
Product Classification Test, time, prothrombin - Product Code GJS
Product Neoplastine¿ Cl Plus ¿ (ref. 00375)

Product Usage:
Manual or automated determination of the prothrombin time (PT).
Code Information Lot 250080 (Exp: 02-2018) Lot 251762 (Exp: 02-2019) Lot 251940 (Exp: 12-2018)
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 2		 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 and Original Applicant = AMERICAN BIOPRODUCTS CO.
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