FDA recall Z-1751-2022

Product

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

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

Key facts

Status

Ongoing

Initiation date

2022-07-20

Report date

2022-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Smithfield, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1751-2022