The Recall Desk
ModerateFDA (Devices)·Z-1531-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues

BioMerieux SA is recalling ETEST Tobramycin 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 precautionary recall.

Plain-English summary

BioMerieux SA is recalling specific lots of ETEST Tobramycin TM256 FOAM packaging (Reference no. 522718 and 522758). The recall is due to product stability issues, as the current shelf-life claims for these ETEST products are not supported by internal testing.

The affected products are used to determine the antimicrobial susceptibility of various bacteria. The recall covers specific lot numbers: 1001761650, 1002112440, 1002860460, 1005166530, 1001888970, 1002281590, and 1003590490. The products were distributed worldwide, including in the United States and numerous foreign countries.

Users should stop using the affected lots and contact BioMerieux SA for further instructions.

The recalled product

Product
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 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 — Laboratory Test Kit
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 (6)

  • Reference no. 522718
  • Lot #1001761650
  • 1002112440
  • 1002860460 & 1005166530 and Reference no. 522758
  • Lot #1001888970
  • 1002281590 & 1003590490.

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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