An evaluation is in process.A follow up report will be submitted when the evaluation is completed.The initial report was submitted under manufacturer report number 1628664-2019-00525 ((b)(4), usa as manufacturing site).Upon retrospective review, it was discovered that mfr information was incorrect.This report was created to correct the site of manufacturer ((b)(4)).
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The account generated false elevated alinity c calcium of 3.7, 2.6 mmol/l that repeated 2.0, 1.9, 2.0, 2.0 mmol/l on the same and other analyzers with sample id (b)(6).The account uses a normal range of 2.1 to 2.55 mmol/l.No specific patient information was provided.No impact to patient management was reported.
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