CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
iSED Primary Pump Tubing Spare Part Kit recalled by Alcor Scientific
Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash, distributed nationwide in the US. The recall was initiated on 20 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1751-2022
- FDA event ID
- 90762
- Recalling firm
- Alcor Scientific, Smithfield, RI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jul 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +57 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea
Nationwide FloridaMassachusettsMarylandPennsylvaniaSouth DakotaWisconsin
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot 4/22
Where was it sold?
US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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