Recall Z-1751-2022— Alcor Scientific, Inc.
Class II · Ongoing
Class II FDA medical device recall by Alcor Scientific, Inc., initiated 2022-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Alcor Scientific, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-20
- Firm location
- Smithfield, RI, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.