FDAFDA · Food and drugs·Recall number Z-2166-2014
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Published August 13, 2014 · Recall initiated: June 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for demographic information and test result to be mismatch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Distributor
- Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
- Lot
- Product Code: 5002-0500; Software Versions, 1.4 and 1.6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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