On (b)(6) 2015, the iq200 select instrument was validated for customer use by a beckman coulter application specialist.During validation, the units for casts were set as hpf.The (bec cts) informed the customer that based on north american (na) customer guide to iq®200 series formed particle settings, part number 300-5413 rev cb, casts are normally enumerated at lpf.On 04-dec-2017, the bec application specialist assisted the customer with correlation studies based on the corrected lpf settings for casts which confirmed that manual enumeration and automated enumeration results correlated.The customer was satisfied with the results and has not reported any further issues on the instrument.No other settings required adjustment during the customer call.(b)(4).
|