Device 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
Z-1751-2022
Product summary
- Event
- Event 90762
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 units
- Official record key
device-enforcement:Z-1751-2022
Official wording
Reason: 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
Code information: Lot 4/22
Distribution pattern: US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea
Derived failure modes
-
Unknown
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