The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2547-2018·Announced 2018-08-01

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.

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 (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.
Category
Medical Device — Cell Culture Media
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

Distributed in 11 states:

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 →

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