Z-2525-2016Class II

Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in...

Name: Z-2525-2016 Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2016-06-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-06-22 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays... on 2016-06-22. FDA classified it as Class II and gives the reason as "Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when...". 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-2525-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-08-11
Terminated: 2018-11-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
Reason for recall: Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on June 22, 2016 both in the United States and Outside the US for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers are to contact Siemens Customer Care Center or their local Siemens technical support representative at 800-405-6473. Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available
Quantity in commerce: 977 units
Distribution: Worldwide Distribution -- USA, U.A.E., Algeria, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Product codes and lots: All software versions and serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2525-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2525-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code JHX

K984067Class IIStratus (R) Cs Stat Fluorometric Analyzer, Stratus (R) Cs Ckmb Test PakDade Behring, Inc. / cleared 1999-01-13

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)