The Recall Desk
ModerateFDA (Devices)·Z-0768-2017·Announced 2016-12-21

Beckman Coulter Recalls MicroScan LabPro Data Management System Software

Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a workflow interruption and potential delay in reporting results without mentioning any reported injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Beckman Coulter Inc. is recalling the MicroScan LabPro Data Management System, software intended to manage microbial identification and antimicrobial agent susceptibility testing data for use by trained laboratory personnel. The recall affects 131 units total, with 130 units distributed in the United States and the remainder in Mexico. The specific software version involved is 4.42, associated with part numbers 6000-0050 through 6000-0054 and 6000-0060.

The recall was initiated after Beckman Coulter received and confirmed reports of intermittent and unexpected behavior when loading new panels into a WalkAway instrument. This issue could cause workflow interruptions and potentially delay the reporting of results because the system may be unable to begin processing new panels.

The source text does not specify the corrective action or instructions for affected users. Affected laboratory personnel should contact Beckman Coulter for further information regarding the recall and any necessary remediation steps.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distribution scope not specified by the agency.