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U.S. Department of Health and Human Services

Class 2 Device Recall Neoplastine CI

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  Class 2 Device Recall Neoplastine CI see related information
Date Initiated by Firm July 24, 2018
Create Date September 07, 2018
Recall Status1 Terminated 3 on May 18, 2020
Recall Number Z-2994-2018
Recall Event ID 80826
510(K)Number K922565  
Product Classification Test, time, prothrombin - Product Code GJS
Product Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
REF: 00666

The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
Code Information Lot Number/Exp. Date/UDI 251426 2018-11-30  (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28  (01)03607450006667(11)170228(17)190228(10)251763(241)00666 
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact SAME
973-631-1200
Manufacturer Reason
for Recall		 QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
FDA Determined
Cause 2		 Device Design
Action Diagnostica Stago issued notification on July 24, 2018 to US Customers provided the reason for the notification, actions to be taken to mitigate the risk. Action: If you have in your laboratory, any of the lots among those listed in the appendix, we are asking you to: If it is not already done, run a Quality Control test at every change of vial. Return to your Stago affiliate, by fax or e-mail, the enclosed form completed and confirming that you have read this letter. Questions contact Stago Hotline (1-800-725-0607)
Quantity in Commerce 5 kits
Distribution Nationwide
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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