FDAClass IIDecember 21, 2016

MicroScan LabPro Data Management System. Intended to recall

MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST)…

Why was MicroScan LabPro Data Management System. Intended to recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST)…
Recalling firm
Beckman Coulter Inc.
Quantity
131 units total (130 units in US)
Distribution
Worldwide Distribution -- United States and Mexico.
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls