A customer notified biomerieux of a discrepant result when using the vidas ft4 test kit.On (b)(6) 2016, the free thyroxine (ft4) result was 37.2 pmol/l.Due to patient symptoms and other test results, the physician ordered the serum to be sent to an external lab for additional testing.Results from the external lab were 16.5 pmol/l.The erroneous lab result was reported to the physician and as a result, the patient was incorrectly treated with neo-mercazole (carbinmazole).Furthermore, the patient underwent additional analyses including laboratory tests, ultrasound imaging and consultation with external physicians.An internal biomerieux investigation will be initiated.
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An internal biomérieux investigation was conducted.The quality product laboratory tested one (1) hypothyroid sample, one (1) hyperthyroid sample and two (2) euthyroid samples on the retain for vidas® ft4 lot 1004345610.The results obtained for these four (4) samples were within specification.Compared to the results obtained during the release, the vidas® ft4 lot 1004345610 has not changed.The customer did not provide return sample; therefore, the investigation could not be continued and explanation regarding the customer's results could not be explained with certainty.Additional analysis concluded no other complaints registered for vidas® ft4 lot 1004345610 and no capa or non-conformity for vidas® ft4 lot 1004345610 linked to this complaint.Analysis of batch history records showed no anomaly during the control process.In conclusion, vidas® ft4 lot 1004345610 is performing as expected.
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