| Class 2 Device Recall Freedom EVO2 | |
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
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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
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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 |
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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.
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