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U.S. Department of Health and Human Services

Class 2 Device Recall STA SYSTEM CONTROL N P

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  Class 2 Device Recall STA SYSTEM CONTROL N P see related information
Date Initiated by Firm November 18, 2019
Create Date December 23, 2019
Recall Status1 Open3, Classified
Recall Number Z-0738-2020
Recall Event ID 84402
510(K)Number K943518  
Product Classification Plasma, coagulation control - Product Code GGN
Product STA SYSTEM CONROL N + P (ref. 00678)
Code Information REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760  UDIs: (01)03607450006780(11)171130(17)191130(10)253145(241)00678 (01)03607450006780(11)180131(17)200131(10)253416(241)00678 (01)03607450006780(11)180331(17)200331(10)253655(241)00678 (01)03607450006780(11)180630(17)200630(10)254040(241)00678 (01)03607450006780(11)180731(17)200731(10)254206(241)00678 (01)03607450006780(11)180930(17)200930(10)254401(241)00678 (01)03607450006780(11)181031(17)201031(10)254573(241)00678 (01)03607450006780(11)181130(17)201130(10)254760(241)00678 
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact
973-631-1200
Manufacturer Reason
for Recall		 A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: FIELD SAFETY NOTICE Combined use of the following reagents STA  UNICALIBRATOR (ref. 00675) and STA  DEFICIENT VIII (ref. 00725) STA  DEFICIENT IX (ref. 00724) Dear Customer, You are using the STA  Unicalibrator (00675) and STA  Deficient VIII (00725) and/or STA  Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1. Following the identification of a defect, please see the information below about the reagents and lots listed in Appendix 1. Description: Following a customer complaint, Stago has investigated and confirmed a positive bias on some STA - Unicalibrator levels. These high levels affect tests using STA - Deficient IX and STA - Deficient VIII reagents. Stago has accordingly reduced the concerned Unicalibrator plasma levels (see new levels on the attached lot-specific barcode sheets). According to our internal testing results, the reduced Unicalibrator plasma levels result in a decrease of Factor VIII and IX results on normal and below-normal patient plasmas. This change has no impact on the classification of hemophiliac patients (type A or B) as severe, moderate or mild. The reassignment of the Unicalibrator plasma levels necessitated a change in the acceptance ranges on the corresponding Quality Control plasmas for Factor VIII and IX parameters with the STA - Deficient VIII and IX reagents. You will find new barcode sheets for each lot of the affected reagents in the attachments. Actions: Upon receipt of this letter, we kindly ask you to: - No longer use the values indicated for STA - Deficient VIII and IX reagents on the barcode sheets in your possession (for the reagents & lots listed in Appendix 1). - Use the new barcode sheets (attached): - For STA - Unicalibrator: Use the analyzer-spec
Quantity in Commerce 5,437
Distribution US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GGN and Original Applicant = AMERICAN BIOPRODUCTS CO.
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