The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1524-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues

BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.

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, but the hazard is a stability issue with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

BioMerieux SA is recalling specific lots of ETEST Ciprofloxacin CI 32 Foam products. The recall was initiated because 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.

The recall covers products distributed worldwide, including the United States and numerous foreign countries. Specific lot numbers are identified in the recall documentation. No illnesses or injuries have been reported in connection with this recall.

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

The recalled product

Product
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 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…
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. 508650
  • Lot #1001060450
  • 1001154650
  • 1001212890
  • 1001264540
  • 1001319180
  • 1001390080
  • 1001390440
  • 1001409510
  • 1001409520
  • 1001441760
  • 1001540660
  • 1001589490
  • 1001621240 & 1001656460
  • Reference no. 508658
  • Lot #1001093880
  • 1001154820
  • 1001265110
  • 1001319480
  • 1001390570

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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