FDAFDA · Food and drugs·Recall number Z-0420-2015
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.
Published December 3, 2014 · Recall initiated: September 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and internationally to: Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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