Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Reported: February 1, 2017 Initiated: December 21, 2016 #Z-1101-2017
Product Description
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Reason for Recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Details
- Recalling Firm
- PerkinElmer Health Sciences, Inc.
- Units Affected
- 1 unit (US) 2 units (OUS)
- Distribution
- Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry. Recalled by PerkinElmer Health Sciences, Inc.. Units affected: 1 unit (US) 2 units (OUS).
Why was this product recalled? ▼
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Low. Recall number: Z-1101-2017.
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