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

Recall Z-2095-2017 — ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)

U.S. FDA — Device Enforcement · France · 2017-04-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2095-2017
Date of alert: 2017-04-25
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: BioMerieux SA
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1003149850

Reported risk: False susceptible results

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.

Recall Z-2095-2017 — ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)

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