Catalog Number 700-7177-001 |
Device Problems
False Negative Result (1225); Device Operates Differently Than Expected (2913); Pumping Problem (3016)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/26/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Iris field service engineer was sent to the customer location.The fse discovered air in the fluidics from the rinse pump assembly to the syringe.The fse replaced the rinse pump assembly p/n: 700-7513 to resolve the control failure.The fse reran the controls and the controls passed.The system was operational.(b)(4).
|
|
Event Description
|
The customer reported failing (b)(6) quality controls for multiple analytes.The customer preformed a cleaning procedure and they were still failing controls.There were no erroneous results generated or reported out of the lab.
|
|
Search Alerts/Recalls
|