Z-1704-2017 Class II Terminated
FDA device recall Z-1704-2017 was initiated by Beckman Coulter Inc. on February 13, 2017 and is designated Class II. Reason for recall: Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match. The recall status is terminated (terminated April 12, 2017). Affected quantity: 2 sheets (20 labels/sheet).
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- February 13, 2017
- Termination Date
- April 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 sheets (20 labels/sheet)
Product 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 for Recall
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Distribution Pattern
US Distribution : MA ., Internationally to Japan
Code Information
Not applicable