Z-0253-2013Class III

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the...

Name: Z-0253-2013 Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-08-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-08-03 / Terminated / root cause: packaging

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine... on 2012-08-03. FDA classified it as Class III and gives the reason as "Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0253-2013
Classification: Class III
Status: Terminated
Initiated: 2012-08-03
Posted: 2012-11-06
Terminated: 2014-01-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) 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: Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Root cause tag: packaging
FDA root cause: Packaging
Action: Siemens sent a Urgent Field Safety Notice letter 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. At this time Siemens Healthcare Diagnostics is conducting a voluntary recall for Dimension Vista HCYS Flex reagent cartridge lots 12062MA and 12066MA. Please immediately discontinue use and discard any remaining inventory of Dimension Vista HCYS (K7044) lots 12062MA and 12066MA. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information. We ask that you forward this notification to anyone to whom you may have distributed this lot. Contact your Siemens Customer Service Center to report your no-charge replacement needs at 888-588-3916. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.
Quantity in commerce: 583 cartons
Distribution: USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
Product codes and lots: Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0253-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0253-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

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