Life Technologies Recalls Gibco MEM Non-Essential Amino Acids Solution
Life Technologies is recalling Gibco MEM Non-Essential Amino Acids Solution (100X) because defective bottle caps may compromise sterility.
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 involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Life Technologies, Corp. is recalling 1,329 units of Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), intended for In-Vitro Diagnostic Use. The recall is due to a defect in the bottle cap that may compromise the sterility of the product.
The affected product includes Lot # 1986670 (Expiration Date 30-Dec-2019) and Lot # 1995631 (Expiration Date 31-Jan-2020). The UDI for the product is 10190302001731. The product was distributed nationwide and in foreign countries including Argentina, Australia, Canada, China, Great Britain, Hong Kong, India, Japan, Mexico, Netherlands, New Zealand, Singapore, South Korea, and Taiwan.
Users should stop using the product and contact Life Technologies, Corp. for further instructions.
The recalled product
- Product
- Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
- Manufacturer
- Life Technologies, Corp.
- Hazard
- Affected units
- 1,329
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Life Technologies, Corp. 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.
See all 4 products in this recall →Related recalls
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