CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports recalled
PerkinElmer Health Sciences is recalling Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, distributed nationwide in the US. The recall was initiated on 1 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0902-2017
- FDA event ID
- 75817
- Recalling firm
- PerkinElmer Health Sciences, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2016
- FDA classified
- 23 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 1 Dec 2016 | Recall initiated by company | |
| 23 Dec 2016 | Classified by FDA | +22 days |
| 4 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
Where it was distributed
Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
Nationwide ArizonaColoradoFloridaGeorgiaIllinoisKentuckyMassachusettsMichiganNew JerseyNevadaOhioSouth Carolina
Questions about this recall
Is Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370 recalled?
Yes. PerkinElmer Health Sciences recalled Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370 on 1 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0902-2017.
Why was it recalled?
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Which lots are affected?
Software Version 1.0
Where was it sold?
Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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