Z-1851-2019Class II

Freedom EVO 200 -

Name: Z-1851-2019 Freedom EVO 200 -
Creator: Tecan US, Inc.
Published: 2019-04-12
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2019-04-12 / Terminated

FDA source

Tecan US, Inc. began a recall of Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic... on 2019-04-12. FDA classified it as Class II and gives the reason as "Gas springs not always replaced within the interval specified". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1851-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-12
Posted: 2019-06-21
Terminated: 2022-01-18
Recalling firm: Tecan U.S.
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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Gas springs not always replaced within the interval specified.
FDA root cause: Under Investigation by firm
Action: In 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 commerce: 40
Distribution: Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1851-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)