FDAClass IINovember 13, 2019

StemPro¿ MSC SFM CTS" recall

StemPro¿ MSC SFM CTS"

Why was StemPro¿ MSC SFM CTS" recalled?

Component was not tested by the supplier for adventitious agents

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
StemPro¿ MSC SFM CTS"
Recalling firm
Life Technologies Corporation
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.
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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