FDA Medical Device Recalls (openFDA)
Life Technologies Corporation: StemPro MSC SFM CTS"
- Recall number
- Z-0274-2020
- Recalling firm
- Life Technologies Corporation
- Product
- StemPro MSC SFM CTS"
- Status
- Terminated
- Initiated
- 2019-06-11
- Posted
- not on file
- Terminated
- 2020-06-04
- Reason
- Component was not tested by the supplier for adventitious agents
- 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 eurotech@thermofisher.com
- Quantity
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K103302"]
- PMA numbers
- not on file
- Product code
- NDS
- Firm FEI
- 1317268
- Firm city
- Grand Island
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28