Z-1851-2019 Class II Terminated
FDA device recall Z-1851-2019 was initiated by Tecan US, Inc. on April 12, 2019 and is designated Class II. Reason for recall: Gas springs not always replaced within the interval specified. The recall status is terminated (terminated January 18, 2022). Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- April 12, 2019
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
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.
Reason for Recall
Gas springs not always replaced within the interval specified.
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.
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.