Reported Dec 3, 2014 · Terminated
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
- Siemens Dimension
- Vista HbA1c Flex reagent cartridgeCatalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot NumbersSiemens
13294BA13308BA13329AA13350AA14006AA14041BA14069BB14083BA
- Dimension HB1C Flex reagent cartridgeCatalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers
GA4266BA4273BA4280BA4287GA4301GA4315GC4322GA4343GA4350GA4357GA5013GA5020
- Amount recalled
- 53, 046
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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