Alcor Scientific, Inc. 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.