Life Technologies Recalls CTSTM Essential 8 Medium Due to Unverified Testing
Life Technologies is recalling 3,693 kits of CTSTM Essential 8 Medium because the component was not tested by the supplier for adventitious agents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves untested components for adventitious agents, which poses a risk of harm, but no specific illnesses or injuries are reported in the source text, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Life Technologies Corporation is recalling 3,693 kits of CTSTM Essential 8 Medium. The recall was initiated because the component was not tested by the supplier for adventitious agents.
The affected product is identified by SKU A2656001 and includes lots 1955886, 1960951, and 2039735, all with expiration dates of January 30, 2019, or January 30, 2020. The product was distributed to specific states in the United States, including California, Florida, Illinois, and New York, as well as to various international locations such as Australia, Canada, China, and the United Kingdom.
Users of this product should stop using it immediately and contact Life Technologies Corporation for further instructions or a refund. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- CTSTM Essential 8 Medium
- Manufacturer
- Life Technologies Corporation
- Affected units
- 3,693
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 (3)
- SKU: A2656001 Lot: 1955886 (Exp1/30/2019)
- 1960951 (Exp1/30/2019)
- 2039735 (Exp1/30/2020)
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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