SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED INCREASED IMPRECISION ON SOME PATIENT SAMPLES WITH THE IMMULITE?/IMMULITE? 1000 CMV 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 CMV 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 CMV IGM KIT LOTS 268 AND ABOVE AND IMMULITE 1000 KIT LOT 332 AND ABOVE.
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Patient 1
THE CUSTOMER HAS INDICATED THAT THEY ARE OBTAINING INCREASED FALSE POSITIVE AND INDETERMINATE RESULTS FOR IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING KIT LOT 260. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE PLATFORM, RESULTING NON-REACTIVE. THE NON-REACTIVE RESULTS OBTAINED ON THE IMMULITE 2000 INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE AND INDETERMINATE CMV IGM RESULTS.