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

Recall Z-1673-2020 — LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instrume

U.S. FDA — Device Enforcement · United States · 2020-01-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1673-2020
Date of alert: 2020-01-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15099590676872

Reported risk: A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.

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

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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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