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
This recall is currently active, issued July 20, 2022. It was issued by Alcor Scientific, Inc..
- Company
- Alcor Scientific, Inc.
- Recall Initiated
- July 20, 2022
- Recall Number
- Z-1751-2022
- Quantity
- 38 units
- Firm Location
- Smithfield, RI
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot 4/22
Root Cause
Nonconforming Material/Component
Action Taken
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 techservice@alcorscientific.com within 3 days. ALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.