Siemens healthcare diagnostics has confirmed the rubella igm reagent lots d236m, d238, 236m, 237, 238, 239, and 239l on the immulite 2000/immulite 2000 xpi systems and reagent lots 333, and 334 on the immulite/immulite 1000 systems exhibit increased imprecision on patient samples.Siemens internal investigation demonstrate that some patient samples exhibit higher percent coefficient of variation (%cv) than the precision performance published in the instructions for use (ifu) for this assay.Quality controls provided in the rubella igm kit may not detect the imprecision with patient results.An urgent field safety notice (ufsn) imc16-20.A.Ous was sent to ous customers and a urgent medical device recall (umdr) imc16-20.A.Us was sent to us customers in august of 2016.The ufsn and umdr state that customers are to discontinue and discard the kits lots affected, and to request a replacement lot.Siemens recommends transitioning to immulite/1000 rubella igm kit lot 0337 and above or to immulite 2000/2000 xpi rubella igm kit lot 240 and above.
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The customer has indicated that they obtained a false positive result on a pregnant patient sample for rubella igm assay on the immulite 2000 instrument when using kit lot 239.The initial result on the patient sample was reactive and the four repeat results were non reactive (2), indeterminate, and non reactive.The control lot provided in the kit was within range when the patient sample was run.The non reactive result was accepted by the physician(s).There were no reports of patient intervention or adverse health consequences due to the false positive result for the rubella igm assay.
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