Z-0428-2026Class II

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Name: Z-0428-2026 Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Creator: Beckman Coulter, Inc.
Published: 2025-10-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-10-01 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer on 2025-10-01. FDA classified it as Class II and gives the reason as "An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0428-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-01
Posted: 2025-11-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/01/2025 via USPS and email. The notice explained the issue, potential impact, and requested the following: If Wash PnP and/or Incubator PnP Z-motion errors appear in the analyzer event log, take the following steps: 1. Attempt to reinitialize the analyzer: a. Go to the Diagnostics screen on the User Interface. b. Select Initialize System. 2. If reinitialization is unsuccessful, contact Beckman Coulter Technical Support in your region. Beckman Coulter recommends posting this letter on or near the affected analyzers. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. A field service representative will contact your laboratory to schedule a time to replace the affected parts. If you have any questions regarding this notice, please contact our Customer Support Center website: http://www.beckmancoulter.com
Quantity in commerce: 80 units
Distribution: Worldwide
Product codes and lots: A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524, 902505, 902578, 902579, 902545, 902530, 902531, 902581, 902504, 902514, 902525, 902535, 902566, 902516, 902518, 902532, 902555, 902558, 902564, 902519, 902521, 902559, 902511, 902549, 902554, 902547, 902582, 902583; A30260, UDI/DI 15099590341602, Serial Numbers: 902536, 902541, 902517, 902563, 902565, 902557, 902513, 902507, 902543, 902560, 902562, 902506, 902508, 902574, 902533, 902572, 902540, 902569, 902568, 902577, 902510, 902580, 902567, 902573, 902570, 902571, 902538, 902553, 902552, 902512, 902539, 902561, 902575, 902544, 902542, 902556, 902537, 902509, 902520, 902546, 902548, 902551, 902550, 902576.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0428-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0428-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0429-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04

Product code JJE

K121790Class IIAccess Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay SystemBeckman Coulter, Inc. / cleared 2013-09-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)