Note: reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).A customer in (b)(6) notified biomérieux of obtaining an out range result for an external instand quality control sample in association with the vidas® fsh 60 tests (ref (b)(4), batch 1007652290).The customer stated out of range low result was obtained when testing instand quality control sample 21.Customer result and specified range are listed below.Sample 21, customer result: 2.65 iu/l, specified range: 2.77 - 4.25 iu/i.As there is no patient associated with this quality control sample, there is no adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.
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This report was initially submitted following notification from a customer in germany regarding out-of-range-low (oorl) results for an eqa sample (instand samples 21 and 22) in association with the vidas fsh assay (ref.(b)(4), lot 1007652290).Sample 21 peer group 3.51 ui / l acceptable range [2.77-4.25] ui / l.Customer's result 2.65 ui / l out of the acceptable range.Sample 22 peer group 70.5 ui / l acceptable range [55.7-85.3] ui / l.Customer's result 55.1 ui / l out of the acceptable range.A biomérieux investigation was conducted; however, the customer did not submit any sample for testing.Evaluation of manufacturing batch records indicated no anomaly during the stages of manufacture, control and packaging.Analysis of several internal serum sera on seven (7) lots of vidas fsh ref.(b)(4), including customer lot, indicated the lot was in specification and in the trend with the other lots.Investigational testing of the implicated lot with four (4) internal samples and two (2) samples of probioqual showed all results obtained comply with the expected and targeted standards.The lot has not drifted since its release.The anomaly was not reproduced.The issue reported by the customer (low results for samples 21 and 22 external quality control instand) was not reproduced by complaints laboratory with sample available in the laboratory.Without the customer's return sample, further investigation and determination of root cause is not possible.The investigation concluded the kit vidas fsh ref.(b)(4), batch 1007652290 / 200922-0 is within the expected performance.There are no other complaints for a similar issue on vidas fsh ref (b)(4), lot 1007652290 / 200922-0.See h10.
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