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Open, Classified

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

FDA Recall Z-1751-2022 · Posted None

Recall StatusOpen, Classified
Product CodeGKB
Date Initiated2022-07-20
Product Quantity38 units

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

Firm Action

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 [email protected] within 3 days. ALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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