Life Technologies Recalls Gibco DMEM Cell Culture Medium Due to Seal Defect
Life Technologies is recalling 70 units of Gibco DMEM cell 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 involves a risk-of-harm product (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 70 units of Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. The affected product is identified by Lot 1932659. This product is a tissue and cell culture medium.
The recall was initiated because the fill port tube seal integrity was compromised during the manufacture of the product lot. This defect may cause the media to leak out of the primary sterile packaging into the outer non-sterile dust cover packaging. Subsequently, mold may grow in the pooled, leaked media.
The product was distributed worldwide, including in the US states of CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA, as well as in Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland. Users should stop using the affected product and contact Life Technologies for further instructions.
The recalled product
- Product
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
- Manufacturer
- Life Technologies, Corp.
- Hazard
- Affected units
- 70
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: 1932659
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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