Device product
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.
Z-1704-2017
Product summary
- Event
- Event 76486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 sheets (20 labels/sheet)
- Official record key
device-enforcement:Z-1704-2017
Official wording
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 information: Not applicable
Distribution pattern: US Distribution : MA ., Internationally to Japan
Derived failure modes
-
Unknown
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.