Siemens healthcare diagnostics has confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 17171bd may produce erroneously low results from specific well sets.If ca reagent calibration is performed using an unaffected well set and qc and patient samples are subsequently processed using an affected well set, ca results may be falsely depressed up to -2.8 mg/dl (-0.7 mmol/l).If ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated.The observed bias for serum, plasma, and urine specimens are similar.Urgent medical device recall, vc-18-03.A.Us and urgent field safety notice vc-18-03.A.Ous dated january, 2018 were issued to customers who had been shipped dimension vista® calcium (ca) flex® reagent lot 17171bd.Customers were instructed to discontinue use and to discard lot 17171bd.
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Discordant falsely depressed calcium (ca) results were obtained on quality control samples on the dimension vista 1500 instrument s/n (b)(4).The customer stated there was no impact on the patient results.There is no known report of any delays in reporting, patient intervention, or adverse health consequences due to the discordant falsely depressed ca qc results.
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