Class II — Alcor Scientific, Inc.
| Recalling firm | ALCOR Scientific LLC |
|---|---|
| Registered facility | ALCOR SCIENTIFIC LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| 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 |
| Quantity | 38 units |
| Distribution | US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea |
| Initiated | 2022-07-20 |
| Classified | 2022-09-15 |
| Recall number | Z-1751-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Alcor Scientific, Inc. (Z-1751-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90762/
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