FDAClass IIJanuary 4, 2017

Specimen Gate Laboratory 5002-0180 recall: Software Issue

Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data…

Why was Specimen Gate Laboratory 5002-0180 recalled?

Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software Version 1.0

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…
Recalling firm
PerkinElmer Health Sciences, Inc.
Quantity
21
Distribution
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
Recall date
January 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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