FDAJuly 20, 2022device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
alcor scientificalcor
Recall history
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