Recall Z-0274-2020 · NDS Media, Culture, Ex Vivo, Tissue And Cell
Life Technologies Corporation
StemPro MSC SFM CTS"
| Date | Jun 11, 2019 |
| Status | Terminated |
| 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 su |
| 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, Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103302 | STEMPRO MSC SFM Life Technologies Corporation, Feb 18, 2011 |