Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0127-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Dimension Vista¿ HbA1c

Product Classification:

Class II

Date Initiated: August 14, 2014

Date Posted: November 5, 2014

Recall Number: Z-0127-2015

Event ID: 69334

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

Status: Terminated

Product Quantity: 20043

Code Information:

catalog #K3105A, material #10470481, All in-date lots

Distribution Pattern:

Worldwide Distribution: US (nationwide) and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated