The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2546-2018·Announced 2018-08-01

Life Technologies Recalls Gibco RPMI 1640 Medium Due to Seal Integrity Issues

Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.

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 (compromised sterile integrity leading to mold growth) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Life Technologies, Corp. is recalling 10 units of Gibco RPMI 1640 Medium, Model Number 61870150, Lot 1930752. This product is a tissue and cell culture medium used in laboratory settings.

The recall was initiated because the fill port tube seal integrity was compromised during the manufacture of the specific 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 affected product was distributed worldwide, including in the United States (CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA), Canada, France, Great Britain, Japan, Korea, the Netherlands, and Switzerland. Users should stop using the affected lot and contact Life Technologies for further instructions.

The recalled product

Product
Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
Manufacturer
Life Technologies, Corp.
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
10

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: 1930752

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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