FDA
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the
iSED Automated ESR Analyzer
PN: 112-13-002
Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube
Alcor Scientific notified consignees via Emails on 21 July 2022 that included an Advisory Notice (AN-001). Letter states reason for recall, health risk and action to take:
" Remove from your inventory any Lot 4/22 Primary Pump Tubing Spare Part Kits (112-13-002). Destroy this tubing.
" If the tubing has been installed on any iSED ESR Analyzers, the tubing must be immediately replaced with new Primary Pump Tubing (112-13-002) from any other lot and Alcor must be notified of the locations where that tubing was installed.
" Complete this form and return via email to techservice@alcorscientific.com within 3 days.
ALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.