Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error
Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to inaccurate diagnostic results, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Beckman Coulter Inc. is recalling the MicroScan LabPro Information Manager System, software versions 1.0 through 4.11, Catalog No. 10714149 and 10714150. The software is intended to manage microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
The recall is due to a software defect that incorrectly allows the operator to manually edit carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. This error could affect the accuracy of the test results.
The affected units were distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and South America. Users of the affected software versions should contact Beckman Coulter for instructions on how to resolve the issue.
The recalled product
- Product
- MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- Version 1.0 to Version 4.11
Distribution
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