Z-0275-2020 Class II Terminated
FDA device recall Z-0275-2020 was initiated by Life Technologies Corporation on June 11, 2019 and is designated Class II. Reason for recall: Component was not tested by the supplier for adventitious agents The recall status is terminated (terminated June 4, 2020). Affected quantity: 3693 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- June 11, 2019
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3693 Kits
Product Description
Reason for Recall
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.