Z-2241-2016Class II

Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro...

Name: Z-2241-2016 Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro...
Creator: CSL Behring GmbH
Published: 2016-05-17
License: https://open.fda.gov/license/

CSL Behring LLC / initiated 2016-05-17 / Terminated / root cause: labeling and UDI

FDA source

CSL Behring GmbH began a recall of Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of... on 2016-05-17. FDA classified it as Class II and gives the reason as "Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2241-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Posted: 2016-07-19
Terminated: 2018-02-07
Recalling firm: CSL Behring LLC
Product: Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.
Quantity in commerce: 898 units
Distribution: Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
Product codes and lots: Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2241-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)