Z-0274-2020Class II

StemPro MSC SFM CTS"

Name: Z-0274-2020 StemPro MSC SFM CTS"
Creator: Life Technologies Corporation
Published: 2019-06-11
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2019-06-11 / Terminated / root cause: supplier

FDA source

Life Technologies Corporation began a recall of StemPro MSC SFM CTS" on 2019-06-11. FDA classified it as Class II and gives the reason as "Component was not tested by the supplier for adventitious agents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0274-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-11
Posted: 2019-11-06
Terminated: 2020-06-04
Recalling firm: Life Technologies Corporation
Product: StemPro MSC SFM CTS"
Product code: NDS Media, Culture, Ex Vivo, Tissue And Cell
Reason for recall: Component was not tested by the supplier for adventitious agents
Root cause tag: supplier
FDA root cause: Vendor change control
Action: 1. Examine your inventory immediately to determine if you have any of the referenced material on hand. 2. If so, discontinue use immediately and discard per your local laws and regulations. 3. Notify all affected users in your facility. 4. If you have shipped this lot outside of your facility, notify those customers or facilities of this recall. To EMEA cutomers: please complete the customer response sheet if you have confirmed visual evidence of media between the media bag and dust cover in your material. Email a copy of the response sheet along with the recall letter to your local order support team. If you have nay question, please call Technical support at 00 800 5345 5345 option 3 or email at [email protected]
Quantity in commerce: 4724 Kits
Distribution: StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI. StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Malaysia, Netherlands, Pakistan, Poland, Republic of Korea, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam. CTSTM Essential 8 Medium distributed to the following states in the USA: CA, DC, FL, IA, IL, MA, MD, MN, NC, NY, WA, WI. CTSTM Essential 8 Medium distributed Internationally to the following countries: Australia, Canada, China, France, Germany, India, Japan, Netherlands, Portugal, Republic of Korea, Saudi Arabia, Singapore, Sweden, Switzerland, Taiwan, United Kingdom.
Product codes and lots: SKU#: A1033301; Lot # 556094 (Exp 2/28/2010), 577934 (Exp 4/30/2010) , 883643 (Exp 12/30/2011), 987595 (Exp 6/30/2013), 1607880 (Exp 6/30/2016), 1936294 (Exp 11/30/2019), 1960237 (Exp 4/30/2020), 2015107 (Exp 10/30/2020), 2049317 (Exp 11/30/2020), 2074105 ( Exp2/28/2021)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0274-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0274-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-06
Z-0275-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-06

Product code NDS

K103302Class IIStempro Msc SfmLife Technologies Corporation / cleared 2011-02-18

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)