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Recall Observatory FDA recall evidence

Device product

CTSTM Essential 8 Medium

Z-0275-2020

June 11, 2019

Class II

Product summary

Firm
Life Technologies Corporation
Event
Event 83301
Status
Terminated
Classification
Class II
Quantity
3693 Kits
Official record key
device-enforcement:Z-0275-2020

Official wording

Reason: Component was not tested by the supplier for adventitious agents

Code information: SKU: A2656001 Lot: 1955886 (Exp1/30/2019), 1960951 (Exp1/30/2019), 2039735 (Exp1/30/2020)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Component was not tested by the supplier for adventitious agents