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

Company

Alcor Scientific, Inc.

Recall Initiated

July 20, 2022

Recall Number

Z-1751-2022

Quantity

38 units

Firm Location

Smithfield, RI

Reason for Recall

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

Distribution

US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea

Lot / Code Info

Lot 4/22

Root Cause

Nonconforming Material/Component

Action Taken

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.