Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Neoplastine CI Plus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Neoplastine CI Plus 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-2993-2018
Recall Event ID 80826
510(K)Number K922040  
Product Classification Test, time, prothrombin - Product Code GJS
Product Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
(REF 00667)

The STA¿ - N¿oplastine¿ CI Plus 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 250791 2018-07-31  (01)03607450006674(11)160731(17)180731(10)250791(241)00667; 250792 2018-07-31 (01)03607450006674(11)160731(17)180731(10)250792(241)00667; 250911 2018-08-31 (01)03607450006674(11)160831(17)180831(10)250911(241)00667; 251231 2018-10-31  (01)03607450006674(11)161031(17)181031(10)251231(241)00667; 251311 2018-11-30 (01)03607450006674(11)161130(17)181130(10)251311(241)00667; 251364 2018-11-30 (01)03607450006674(11)161130(17)181130(10)251364(241)00667; 251427 2018-11-30  (01)03607450006674(11)161130(17)181130(10)251427(241)00667; 251528 2018-12-31  (01)03607450006674(11)161231(17)181231(10)251528(241)00667; 251707 2019-01-31  (01)03607450006674(11)170131(17)190131(10)251707(241)00667; 251708 2019-01-31  (01)03607450006674(11)170131(17)190131(10)251708(241)00667; 251767 2019-02-28  (01)03607450006674(11)170228(17)190228(10)251767(241)00667; 251800 2019-02-28  (01)03607450006674(11)170228(17)190228(10)251800(241)00667; 252534 2019-07-31  (01)03607450006674(11)170731(17)190731(10)252534(241)00667; 252737 2019-09-30  (01)03607450006674(11)170930(17)190930(10)252737(241)00667 
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 24043 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.
-
-