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 EVO2see related information
Date Initiated by FirmApril 12, 2019
Create DateJune 21, 2019
Recall Status1 Terminated 3 on January 18, 2022
Recall NumberZ-1851-2019
Recall Event ID 82822
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductFreedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
Code Information Freedom EVO 200 BASE UNIT 10641200 and 10641541 Freedom EVO 200 MCA96 BASE UNIT 30020020 Freedom EVO 200 MCA384 BASE UNIT 30032020 Freedom EVO 200-2 LiHa BASE UNIT 10641202  Serial Numbers 222, 702, 714, 506000013, 511000005, 603000004, 702000004, 703000002, 703000005, 703000006, 707001360, 710000367, 801002513, 801003121, 802003688, 805002719, 809002562, 810000017, 812002002, 906005647, 908002944, 910006632, 1004001243, 1006000274, 1006009336, 1009002730, 1011003146, 1011004081, 1011004086, 1011004089, 1011004095, 1104000151, 1108006349, 1108006724, 1108006777, 1109000886, 1109001036, 1109006938, 1111008689, and 1203005259. 
FEI Number 1037985
Recalling Firm/
Manufacturer		 Tecan US, Inc.
9401 Globe Center Dr Ste 140
Morrisville NC 27560-6211
For Additional Information ContactLaura Nea
919-943-7118
Manufacturer Reason
for Recall		Gas springs not always replaced within the interval specified.
FDA Determined
Cause 2		Under Investigation by firm
ActionIn April 2019, Tecan US sent Field Corrective Action Freedom EVO 200 letters to their US and Canadian consignees advising them of the issue; requesting that they complete and return an acknowledgement receipt; to pass the letter to any organization where the devices may be transferred and to arrange for a Tucan US representative to replace the gas springs
Quantity in Commerce40
DistributionWorldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.
Total Product Life CycleTPLC 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.
-
-