Alcor Scientific, Inc. recalls iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration need…

Recall date

July 20, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1751-2022

FDA classification

Class II

Brand / firm

Alcor Scientific, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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