Life Technologies Recalls StemPro MSC SFM CTS Kits for Unverified Safety
Life Technologies is recalling 4,724 kits of StemPro MSC SFM CTS because the supplier did not test the components for adventitious agents.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a critical safety test for adventitious agents was not performed. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Life Technologies Corporation is recalling 4,724 kits of StemPro MSC SFM CTS. The recall was initiated because the component was not tested by the supplier for adventitious agents. The affected product is identified by SKU A1033301 and includes specific lot numbers with expiration dates ranging from 2010 to 2021.
The recalled product was distributed to various states in the United States, including Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington, and Wisconsin. It was also distributed internationally to numerous countries, including 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, and Vietnam.
Consumers and healthcare facilities should stop using the affected product and contact Life Technologies Corporation for further instructions or a refund.
The recalled product
- Product
- StemPro¿ MSC SFM CTS"
- Manufacturer
- Life Technologies Corporation
- Affected units
- 4,724
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Life Technologies Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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