FDA Device recall Z-1751-2022
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the read…
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the read… by Alcor Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-20 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcor Scientific |
| Distribution | US |
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
Identifiers
| code_info | Lot 4/22 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1751-2022%22
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