LabPro Data Management System — Class II medical device recall Z-1673-2020
Terminated recall by Beckman Coulter Inc., reported 2020-04-15, distributed nationwide. A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 ope
| Recall number | Z-1673-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-01-17 |
| Classified | 2020-04-06 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, DE, MX |
| Quantity | 177 systems |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 15099590676872 |
Product
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 instruments or manually entered microbiology test results, for use by trained laboratory personnel.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1673-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.