Siemens healthcare diagnostics has confirmed that the dimension® hb1c flex® reagent cartridge lots ga4266, ba4273, ba4280, ba4287, ga4301, ga4315, gc4322, ga4343, ga4350, ga4357, ga5013, and ga5020 exhibit a 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 bias resulted in complaints for college of american pathologists (cap) survey failures.In the urgent medical device recall letter dated september 2014, #14-60 issued to customers who were shipped the impacted lots, siemens directed customers to discontinue use and to discard the impacted lots.Siemens stated it would replace any unused inventory of the affected lots at no charge with a non-affected lot.
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