FDA Enforcement
Class II
Terminated
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.
Recall: Z-1704-2017
·
Reported April 12, 2017
Enforcement
- Recall Number
- Z-1704-2017
- Event ID
- 76486
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 12, 2017
- Initiation Date
- February 13, 2017
- Classification Date
- April 3, 2017
- Termination Date
- April 12, 2017
- Address
- 250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States
Description
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.
Reason
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Code Info
Not applicable
Distribution
US Distribution : MA ., Internationally to Japan
Quantity
2 sheets (20 labels/sheet)