Z-0541-2014Class II

Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test...

Name: Z-0541-2014 Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-09-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-09-18 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total... on 2013-09-18. FDA classified it as Class II and gives the reason as "Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0541-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Posted: 2013-12-19
Terminated: 2014-10-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be taken by Customer: Please discontinue use and discard any remaining inventory of Dimension Vista HCYS Flex reagent cartridge (Catalog# K7044) lot 13064MA. Please complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center- Technical Solutions or your local Siemens technical support representative. For further questions please call (800) 441-9250.
Quantity in commerce: 302
Distribution: Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.
Product codes and lots: lot 13064MA, expiration 2014-03-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0541-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0541-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

Product code LPS

K063206Class IIDimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, HighDade Behring, Inc. / cleared 2006-12-28

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