Z-0784-2024Class II

Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

Name: Z-0784-2024 Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Creator: Beckman Coulter, Inc.
Published: 2023-12-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-12-19 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 on 2023-12-19. FDA classified it as Class II and gives the reason as "Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0784-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-19
Posted: 2024-01-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Product code: LKM Counter, Urine Particle
Reason for recall: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
FDA root cause: Other
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/19/2023 via first class mail and email. The notice explained the issue, its impact on test results, and requested the following actions be taken: - Continue to run a complete Quality Control (QC) rack [including Iris Cleanser, Iris Diluent, iQ Focus and iQ Controls] as directed per iQ200 Series Instructions for Use (IFU) (300-4320 CE or 300-4321 EE) and DxU 850m and 840m Iris IFU (C49320 AB) - If the QC passes: o Run patient samples as routine - If the QC fails: o Refer to the IFU, Chapter 10 Troubleshooting; iQ200 Series IFU or DxU 850m and 840m Iris IFU o If the failure persists, contact your Beckman Coulter Representative - If a "Sequential Flags" Alarm displays: Refer to the IFU, Chapter 10; Alarm #25; iQ200 Series IFU or DxU 850 and 840m Iris IFU o If the alarm persists, contact your Beckman Coulter Representative Additional weekly action if using DxU 850m/840m Microscopy Analyzers: Visually inspect the iQClear Rinse Waste Well jets weekly for rust o If the iQClear shows rust on the rinse jets, contact your Beckman Coulter Representative Consult with your laboratory management to determine whether a retrospective review of results is necessary. For questions regarding this notice, please contact Customer Support Center or your local representative; From our website: http://www.beckmancoulter.com By phone: call 800-526-7694 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in commerce: 254 units
Distribution: US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland,
Product codes and lots: C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0784-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0785-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0786-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0787-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25

Product code LKM

K022774Class IIIq 200 SystemIntl. Remote Imaging Systems / cleared 2002-10-21

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)