The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1528-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Fosfomycin Strips Due to Unsupported Shelf-Life Claims

BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

BioMerieux SA is recalling ETEST Fosfomycin FM1024 Blister packaging, a quantitative technique used to determine the antimicrobial susceptibility of various bacteria. The recall was initiated because the current shelf-life claims for these products are not supported by internal testing.

The affected products are distributed worldwide, including nationwide in the United States and in numerous foreign countries. The recall covers specific reference numbers and lot numbers, including Reference no. 529140, 529148, 529100, and 529108.

Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas…
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. 529140
  • Lot #1001390510
  • 1001441860
  • 1001609400
  • 1001733320
  • 1001761030
  • 1001920530
  • 1001966610
  • 1002009360
  • 1002084930
  • 1002106570
  • 1002158050
  • 1002168110
  • 1002395840
  • 1002452170
  • 1002500020
  • 1002604960
  • 1002992250
  • 1003030810
  • 1003127520

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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