The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0173-2019·Announced 2018-10-24

Life Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps

Life Technologies is recalling 41 units of Gibco Sodium Pyruvate (100 mM) because defective bottle caps may compromise product sterility.

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 is classified as FDA Class II. The hazard involves compromised sterility, which is a risk-of-harm condition where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Life Technologies, Corp. is recalling 41 units of Gibco Sodium Pyruvate (100 mM), SKU 11360070, intended for In-Vitro Diagnostic Use. The recall is due to a defect in the bottle cap that causes the bottles to leak, which compromises the sterility of the product.

The affected product is identified by Lot # 1967697, with an expiration date of 30-Jun-2019 and UDI 10190302001823. The agency classifies this recall as Class II.

The product was distributed nationwide and in foreign locations including Argentina, Australia, Canada, China, Great Britain, Hong Kong, India, Japan, Mexico, Netherlands, New Zealand, Singapore, South Korea, and Taiwan. Users should stop using the affected product and contact the manufacturer for instructions.

The recalled product

Product
Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Manufacturer
Life Technologies, Corp.
Category
Medical Device — In-Vitro Diagnostic Reagent
Hazard
Affected units
41

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# 1967697 Exp. Date 30-Jun-2019. (UDI 10190302001823)

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 →

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