The Recall Desk
HighFDA (Devices)·Z-0174-2019·Announced 2018-10-24

Life Technologies Recalls Gibco GlutaMAX Supplement Due to Leaky Bottles

Life Technologies is recalling 1,912 units of Gibco GlutaMAX Supplement because defective bottle caps may compromise the product's sterility.

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. The hazard involves compromised sterility, which poses a risk of harm to the product's integrity, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Life Technologies, Corp. is recalling 1,912 units of Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use (SKU 35050061). The recall is due to a defect in the bottle cap that results in leaky bottles, which compromises the sterility of the product.

The affected product is identified by Lot Number 1967697 (UDI 10190302001823) and has an expiration date of 30-Jun-2020. 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 of the product should stop using the affected units and contact Life Technologies, Corp. for further instructions or a refund.

The recalled product

Product
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Affected units
1,912

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 Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020

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 →