The Recall Desk
ModerateFDA (Devices)·Z-1530-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Gentamicin Strips Due to Stability Issues

BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a stability/shelf-life issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

BioMerieux SA is recalling specific lots of ETEST Gentamicin GM256 FOAM packaging (ETEST Gentamicin GM 0.016-256 low). The recall is due to product stability issues, specifically that the current shelf-life claims for these products are not supported by internal testing.

The affected products are distributed worldwide, including in the United States and numerous foreign countries. The ETEST system is a quantitative technique used to determine the antimicrobial susceptibility of various bacteria by measuring the Minimum Inhibitory Concentration (MIC) of antimicrobial agents.

Users should stop using the affected lots and contact BioMerieux SA for further instructions or a return. The specific lot numbers and reference numbers are listed in the official recall notice.

The recalled product

Product
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (20)

  • Reference no. 512550
  • Lot # 1002001100 & 1002048740
  • Reference no. 512510
  • Lot #1001970170 & 1002154750
  • Reference no. 512558
  • Lot #1001564260
  • 1001676270
  • 1001733240
  • 1001793760
  • 1001873760
  • 1002113320
  • 1002230930
  • 1002559800
  • 1002823250
  • 1003495040
  • 1003883840
  • 1004248160
  • 1004252230
  • 1004277880
  • 1004567040

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by BioMerieux SA 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 12 products in this recall →

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