The Recall Desk
ModerateFDA (Devices)·Z-1523-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

BioMerieux SA is recalling ETEST Ceftriaxone 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, and the hazard involves unsupported shelf-life claims (stability issues) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

BioMerieux SA is recalling ETEST Ceftriaxone TXL32 SPB and ETEST Ceftriaxone TX 0.002-32(low) antimicrobial susceptibility testing strips. 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 used to determine the antimicrobial susceptibility of various bacteria, including Gram-negative and Gram-positive aerobic bacteria. The recall covers specific lots of Reference no. 412302 and Reference no. 412303, which were distributed worldwide, including nationwide in the United States and in numerous foreign countries.

Healthcare facilities and laboratories should stop using the affected lots and contact BioMerieux SA for further instructions or replacement.

The recalled product

Product
ETEST¿ Ceftriaxone TXL32 SPB, 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, Staphylococcus and Ent
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Diagnostic
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. 412302
  • Lot #1002939460
  • 1003361690
  • 1003848910
  • 1004041770
  • 1004394530
  • 1004731200 & 1004876830 and Reference no. 412303
  • Lot # 1002939450
  • 1003089900
  • 1003813690
  • 1003851120
  • 1003953500
  • 1004152070
  • 1004315690
  • 1004394520
  • 1004525320
  • 1002939450
  • 1004755940
  • 1004828440
  • 1004876840 & 1005118100.

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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