Z-1751-2022 Class II Ongoing
FDA device recall Z-1751-2022 was initiated by Alcor Scientific, Inc. on July 20, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 38 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- July 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
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
Distribution Pattern
US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea
Code Information
Lot 4/22