The Recall Desk
ModerateFDA (Devices)·Z-1532-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.

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 hospitalizations, injuries, or illnesses. The hazard is a stability issue where shelf-life claims are unsupported, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

BioMerieux SA is recalling specific lots of ETEST Ceftriaxone TXL32 FOAM packaging (Product Name: ETEST Ceftriaxone TX 0.002-32(low)). The recall was initiated because the current shelf-life claims for these products are not supported by internal testing. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products are used to determine the antimicrobial susceptibility of various bacteria. The recall includes specific reference numbers and lot numbers, including Reference no. 507058 and Reference no. 507018. The products were distributed worldwide, including in the United States and numerous foreign countries.

Consumers and healthcare facilities should stop using the affected lots and contact BioMerieux SA for further instructions or a replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcu
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. 507058
  • Lot #1002940890
  • 1003128150
  • 1003361950
  • 1003849820
  • 1004041790
  • 1004239890
  • 1004395510
  • 1004525370
  • 1004756050
  • 1004828430
  • 1004876860
  • 1004919030 and Reference no. 507018
  • Lot #1002940880
  • 1003182290
  • 1003813700
  • 1003851130
  • 1003953490
  • 1004239880
  • 1004316460

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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