Siemens healthcare diagnostics has confirmed increased imprecision on some patient samples with the immulite®/immulite® 1000 (b)(4) igm reagent lots 330 and 331 and on the immulite® 2000 / immulite® 2000 lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, and 267.These samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across nonreactive, indeterminate, and reactive ratios.Quality controls provided in the (b)(4) igm kit may not detect the imprecision with patient results.An urgent field safety notice (ufsn) imc 16-22a.Ous was sent out to customers and an urgent medical device recall (umdr) imc16-22.A.Us was sent to us customers in august 2016.The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lots listed above.Siemens recommends transitioning to immulite 2000/2000 xpi (b)(4) igm kit lots 268 and above and immulite 1000 kit lot 332 and above.
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The customer has indicated that they are obtaining increased (b)(6) and indeterminate results for igm antibodies to (b)(4) assay on an immulite 2000 instrument when using kit lot 262.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, some of which resulted (b)(6) and others were still (b)(6).The samples were then repeated on the alternate platform, resulting (b)(6).It is unknown if the (b)(6) results were reported to the physician(s).There were no reports of patient intervention or adverse health consequences due to the (b)(6) results.
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