Z-0127-2015Class II

Dimension Vista HbA1c

Name: Z-0127-2015 Dimension Vista HbA1c
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-08-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-14 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista HbA1c on 2014-08-14. FDA classified it as Class II and gives the reason as "In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0127-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Posted: 2014-10-24
Terminated: 2015-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista HbA1c
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Correction, dated August 2014, was provided to all Dimension Vista HbA1c customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.
Quantity in commerce: 20043
Distribution: Worldwide Distribution: US (nationwide) and country of: Canada.
Product codes and lots: catalog #K3105A, material #10470481, All in-date lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0127-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0127-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code LCP

K102045Class IIDimension Visa Hba1c, Model K3105aSiemens Heatlhcare Diagnostics, Inc. / cleared 2011-02-14

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)