The Recall Desk
ModerateFDA (Devices)·Z-1529-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues

BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current 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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a stability issue regarding shelf-life claims, which fits the criteria for a moderate severity recall involving potential product degradation without reported harm.

Plain-English summary

BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging, a quantitative technique used to determine the antimicrobial susceptibility of various bacteria. The recall is being conducted because 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. Specific reference numbers and lot numbers are listed in the recall documentation.

Consumers and healthcare facilities should stop using the affected ETEST Imipenem IP32 Foam packaging and contact BioMerieux SA for further instructions or a replacement.

The recalled product

Product
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entero
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 (20)

  • Reference no. 513610
  • Lot #1001125240 & 1001610770
  • Reference no. 513618
  • Lot #1001193130
  • 1001223300
  • 1001316710
  • 1001377740
  • 1001454060
  • 1001454090
  • 1001527340
  • 1001633670
  • 1001721100
  • 1001801280
  • 1001804930
  • 1002029820
  • 1002234950
  • 1002238110
  • 1002269280
  • 1002476170
  • 1002593870

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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