Beckman Coulter Inc. recalls MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10…

Recall date

February 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1269-2016

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, P…

Why it was recalled

Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit Europe: 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software USA: 10714149, LabPro v4.11 Software Update Kit 10714150 LabPro v4.11 System Software 10975000 ASM LabPro-MBT v4.40 10975001 ASM LabPro-MBT v4.40 for Connect 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit ROW: 6000-0008 LabPro v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software Product Usage: 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. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.