Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-1704-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 13, 2017

Date Posted: April 12, 2017

Recall Number: Z-1704-2017

Event ID: 76486

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.

Status: Terminated

Product Quantity: 2 sheets (20 labels/sheet)

Code Information:

Not applicable

Distribution Pattern:

US Distribution : MA ., Internationally to Japan

Voluntary or Mandated:

Voluntary: Firm initiated