Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect
Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.
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 is classified as FDA Class II, and the hazard involves a risk of harm (mold growth in sterile media) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Life Technologies, Corp. is recalling 91 units of Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. The affected product is a tissue and cell culture medium with Lot number 1945238.
The recall was initiated because the fill port tube seal integrity was compromised during manufacture. This defect may cause the media to leak from the primary sterile packaging into the outer non-sterile dust cover packaging, creating conditions where mold may grow in the pooled, leaked media.
The product was distributed worldwide, including in the United States (CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA) and in Canada, France, Great Britain, Japan, Korea, the Netherlands, and Switzerland. Users should check their inventory for the specific lot number and discontinue use if found.
The recalled product
- Product
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
- Manufacturer
- Life Technologies, Corp.
- Affected units
- 91
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 (1)
- Lot: 1945238
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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