Z-1362-2018Class II

BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683...

Name: Z-1362-2018 BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683...
Creator: Beckman Coulter Inc.
Published: 2018-03-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-02 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370 on 2018-03-02. FDA classified it as Class II and gives the reason as "Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1362-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-02
Posted: 2018-04-11
Terminated: 2023-07-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
Product code: KQO Automated Urinalysis System
Reason for recall: Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
Root cause tag: software
FDA root cause: Use error
Action: The customers were contacted initially by the Urgent Medical Device Recall letter on 03/028/2018 delivered by email and US Mail. Beckman Coulter will schedule a sites visit to verify the reporting units of measurement for casts for the laboratory within 90 days of this recall initiation. The use of Casts/HPF is not a common setting worldwide.
Quantity in commerce: 5247 units
Distribution: Worldwide
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1362-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1362-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11

Product code KQO

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