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

Recall Z-0913-2013 — Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.

U.S. FDA — Device Enforcement · United States · 2012-11-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0913-2013
Date of alert: 2012-11-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.

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-0913-2013 — Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.

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