Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0420-2015)

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:

Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Product Classification:

Class II

Date Initiated: September 30, 2014

Date Posted: December 3, 2014

Recall Number: Z-0420-2015

Event ID: 69434

Reason for Recall:

Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.

Status: Terminated

Product Quantity: 53, 046

Code Information:

Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020

Distribution Pattern:

Worldwide Distribution: US (nationwide) and internationally to: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated