Z-1545-2014Class III

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946

Name: Z-1545-2014 CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946
Creator: Siemens Healthcare Diagnostics Inc
Published: 2013-02-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-02-26 / Terminated

FDA source

Siemens Healthcare Diagnostics Inc began a recall of CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946 on 2013-02-26. FDA classified it as Class III and gives the reason as "Device with Sample Interference Notes (SIN) enabled not cleared for US marketing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1545-2014
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Posted: 2014-05-04
Terminated: 2014-05-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Product code: KQO Automated Urinalysis System
Reason for recall: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
FDA root cause: Reprocessing Controls
Action: On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
Quantity in commerce: 1 unit
Distribution: US Distribution in the state of: CA.
Product codes and lots: Serial Number: 212809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1545-2014	Class III	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-04

Product code KQO

K091216Class IIClinitek Status+analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics / cleared 2009-10-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)