PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue
PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.
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. The hazard involves software malfunction (disk space exhaustion) which is a functional defect rather than a direct physical safety hazard like injury or death, fitting the Moderate category for low-risk operational issues.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling 21 units of Specimen Gate Laboratory (5002-0180) and Specimen Gate eReports (5002-0370), Software Version 1.0. These products are data processing software intended for the storage, retrieval, and processing of laboratory data, with eReports specifically supporting newborn screening laboratories, hospitals, and clinicians in data management and report generation.
The recall was initiated because a software issue may cause the eReports module to consume an excessive amount of disk space. This behavior can result in the software stopping its operation. The affected units were distributed worldwide, including in the United States (CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY) and internationally to Italy, Ireland, the UK, Spain, and Peru.
Users of the affected software should contact PerkinElmer Health Sciences for further instructions on how to resolve the issue or obtain a replacement.
The recalled product
- Product
- Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module o
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Affected units
- 21
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)
- Software Version 1.0
Distribution
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