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Recall Observatory FDA recall evidence

Device product

Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.

Z-1851-2019

April 12, 2019

Class II

Product summary

Firm
Tecan US, Inc.
Event
Event 82822
Status
Terminated
Classification
Class II
Quantity
40
Official record key
device-enforcement:Z-1851-2019

Official wording

Reason: Gas springs not always replaced within the interval specified.

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.

Distribution pattern: Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Gas springs not always replaced within the interval specified.