Z-1704-2017Class II

Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter...

Name: Z-1704-2017 Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter...
Creator: Beckman Coulter Inc.
Published: 2017-02-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-02-13 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers... on 2017-02-13. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1704-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-13
Posted: 2017-04-03
Terminated: 2017-04-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support Center: http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada; Outside the United States and Canada, contact their Beckman Coulter representative.
Quantity in commerce: 2 sheets (20 labels/sheet)
Distribution: US Distribution : MA ., Internationally to Japan
Product codes and lots: Not applicable

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1704-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1704-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-03

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)