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 Freedom EVO2

  • 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 Freedom EVO2 see related information
Date Initiated by Firm July 23, 2018
Create Date October 11, 2018
Recall Status1 Terminated 3 on August 26, 2020
Recall Number Z-3187-2018
Recall Event ID 80672
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
Product Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Code Information Part Numbers for Models of Freedom EVO with any version of EVOware:  a. Freedom EVO 100: 10641100, 30020010, 30032010;  b. Freedom EVO 150: 10641150, 10641152, 30020015, 30032015;  c. Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020;   Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971;   Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439. 
Recalling Firm/
Manufacturer		 Tecan US, Inc.
9401 Globe Center Dr Ste 140
Morrisville NC 27560-6211
For Additional Information Contact Laura Nea
919-943-7118
Manufacturer Reason
for Recall		 There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971.
FDA Determined
Cause 2		 Device Design
Action On July 23, 2018, Tecan sent Field Corrective Action Letters to their consignees advising them of the problem. Field corrections will be made in the near future.
Quantity in Commerce 19 EVOware Sample Tracking Software Add-on
Distribution Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
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.
-
-