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[Recalled] 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 En

recall fda device france

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCiprofloxacin 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 Enterococcus species
Brand / manufacturerBioMerieux SA
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1524-2017
Country of noticeFrance
Risk levelClass II
Hazard typerecall
Notice date15 December 2016
EAN / barcode1001060450

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

This Class II recall concerns device products distributed in France and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from BioMerieux SA

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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