Original mdr 2517506-2016-00476 was filed 2016-12-07.Siemens healthcare diagnostics is conducting a recall for the dimension ammonia flex reagent cartridge/amm df119 (smn # 10711991) kit lots (fb7152, eb7180, ba7194, ea7223, ba7250) and dimension vista ammonia flex reagent cartridge / amm k3119 (smn #10711992) kit lots (16187be, 16225bb, 16265ab).Siemens healthcare diagnostics has determined that dimension amm (df119) flex reagent cartridge lots fb7152, eb7180, ba7194, ea7223, ba7250 and dimension vista amm (k3119) flex reagent cartridge flex lots 16187be, 16225bb, 16265ab do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay.These lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the 60-day claim in the instructions for use (ifu).An urgent field safety notices (ufsn's) dc17-01.A.Ous.Dm and dc 17.01a.Ous.Dmv were sent to ous customers and an urgent medical device recalls (umdr's) dc17-01.A.Us.Dm and dc 17.01a.Us.Dmv were sent to us customers in december 2016.The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lot.Siemens recommends using an alternate lot of dimension or dimension vista amm.Siemens is currently investigating the root cause of this issue.
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