iSED Primary Pump Tubing Spare Part Kit- — Class II medical device recall Z-1751-2022
Ongoing recall by Alcor Scientific, Inc., reported 2022-09-21, distributed nationwide. Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there
| Recall number | Z-1751-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcor Scientific, Inc., Smithfield, RI, United States |
| Recall initiated | 2022-07-20 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | HN, HR, KR |
| Quantity | 38 units |
| Reason classes | packaging |
| Lot numbers | 4/22 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1751-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.