Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1524-2017 — 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 Enterococcus species

U.S. FDA — Device Enforcement · France · 2016-12-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1524-2017
Date of alert: 2016-12-15
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: BioMerieux SA
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1001060450

Reported risk: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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