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Recall Observatory FDA recall evidence

Device product

MicroScan LabPro Data Management System. 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.

Z-0768-2017

October 25, 2016

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 75576
Status
Terminated
Classification
Class II
Quantity
131 units total (130 units in US)
Official record key
device-enforcement:Z-0768-2017

Official wording

Reason: Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.

Code information: Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.

Distribution pattern: Worldwide Distribution -- United States and Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.