Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reported: January 10, 2018 Initiated: November 6, 2017 #Z-0308-2018
Product Description
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason for Recall
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 227 units
- Distribution
- Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.. Recalled by Beckman Coulter Inc.. Units affected: 227 units.
Why was this product recalled? ▼
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2018. Severity: Low. Recall number: Z-0308-2018.
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