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

Recall Z-0329-2013 — bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acu

U.S. FDA — Device Enforcement · United States · 2012-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0329-2013
Date of alert: 2012-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices

Reported risk: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.

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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