translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 028 07 18 000

2018-07-05

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12860

The bact/alert® virtuo® instrument firmware version r2.0 allows relocation of the four (4) resident calibration standards so that field system engineers (fse) can service the associated cells p24 - p27, where the calibration standards typically reside. if the calibration standards are not returned to the designated locations, an anomaly may occur. following a reboot via the instrument’s small user interface screen, while patient or test bottles are loaded in cells p24 - p27, the following will occur: 1. the unload date/time will be set to the current date/time, causing the bottle status to be set to “unload” even though the bottle remains in the instrument. 2. the bottle will continue to process; however, in the event of a positive bottle in cells p24 – p27, no indication of a positive bottle will be observed by the user. neither the visual (flashing yellow light) nor audible alarm will occur. 3. although the instrument does not provide alarm to the user, the bottle result (positive or negative) is transferred to the lis (laboratory information system). two consecutive error conditions may also be observed for bottles in cells p24 – p27: 1. an “anonymous bottle” alarm. 2. a “duplicate bottle” alarm. to prevent this anomaly from occurring, your local field service engineer (fse) has confirmed the calibration standards are in the designated bottle cell locations.