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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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
Related recalls
Same manufacturer · PerkinElmer Health Sciences, Inc.
See all →- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2020-06-10
- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2017-08-02
- ModeratePerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
FDA (Devices) · 2017-02-01
- LowPerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
- LowPerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
Same hazard · software malfunction
See all →- HighPhilips PIC iX Essentials Patient Information System Software Recall
FDA (Devices) · 2026-09-23
- HighPhilips Patient Information Center iX Software Malfunction Recall
FDA (Devices) · 2026-09-23
- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
Similar recalls
- SeverePerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors
FDA (Devices) · 2017-04-19
- HighPerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk
FDA (Devices) · 2014-08-13
- SeverePerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
FDA (Devices) · 2018-05-09
- HighPerkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation
FDA (Devices) · 2015-11-04
- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2017-08-02
- ModeratePerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall
FDA (Devices) · 2018-12-05