Recall Z-0274-2020— Life Technologies Corporation

Name: FDA recall Z-0274-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-11

Class II · Terminated

Class II FDA medical device recall by Life Technologies Corporation, initiated 2019-06-11, terminated 2020-06-04. It names one FDA 510(k) clearance: K103302. Product: StemPro¿ MSC SFM CTS". Reason: Component was not tested by the supplier for adventitious agents.

Recalling firm: Life Technologies Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-06-11
Terminated: 2020-06-04
Firm location: Grand Island, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K103302 — STEMPRO MSC SFMLife Technologies Corporation·cleared 2011-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

StemPro¿ MSC SFM CTS"

Reason for recall

Component was not tested by the supplier for adventitious agents

Data sourced from openFDA. This site is unofficial and independent of the FDA.