Z-0408-2013Class II

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an...

Name: Z-0408-2013 Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-08-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative... on 2012-08-09. FDA classified it as Class II and gives the reason as "Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0408-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-11-20
Terminated: 2014-01-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
Product code: KLS Enzyme Immunoassay, Theophylline
Reason for recall: Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare Diagnostic sent a Urgent Field Safety notice dated July, 20. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately discontinue use and discard any remaining inventory of Dimension Vista Theophylline Flex reagent cartridge (THEO, Catalog # K4071) lot 12135AE and/or 12171BB. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information and to facilitate your additional no charge replacement. We ask that you forward this notification to anyone to whom you may have distributed this lot. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. For questions concerning the status of your no charge replacement order please contact your Siemens Customer Service Center at 888-588-3916. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.
Quantity in commerce: 959 cartons
Distribution: USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
Product codes and lots: Lots 12135AE and 12171BB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code KLS

K062024Class IIDimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent CartridgeDade Behring, Inc. / cleared 2006-07-28

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)