Siemens healthcare diagnostics, inc.Has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using advia chemistry lipase reagent lot 485700.Preliminary investigation has indicated that not all cartons within this reagent lot are impacted.An urgent medical device recall (umdr) chc 20-03.A.Us was sent to us customers and an urgent field safety notice (ufsn) chc 20-03.A.Ous was sent to ous customers in december 2019.The umdr and ufsn advise customers of the investigation with the advia chemistry lipase reagent lot 485700 and provide instructions to help determine if the lipase reagent cartons in their inventory are impacted.If the cartons in the customers inventory are not impacted, the customers are instructed to proceed to using the cartons according to the instructions for use.If the cartons in the customers inventory are impacted, the customers are instructed to discard the impacted cartons and can request replacement.The next reagent lot is expected to be available by february 2020.If replacement kits are not available, customers are instructed to test patient samples using an alternate methodology.
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The customer contacted siemens customer care center (ccc) to report that they observed erratic qc and obtained discordant, falsely elevated lipase (lip) patient results using kit lot 485700 on an advia chemistry xpt instrument.The initial discordant, falsely elevated lip patient results were not reported to the physician(s).The same sample was repeated on the same advia chemistry xpt instrument, resulting lower and as expected.None of the results (initial or repeat) were reported since testing was part of a patient comparison study between two lots of lip.There are no known reports of patient intervention or adverse health consequences due to the discordant lip results.
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