Z-1751-2022Class II

iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the...

Name: Z-1751-2022 iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the...
Creator: Alcor Scientific, Inc.
Published: 2022-07-20
License: https://open.fda.gov/license/

Alcor Scientific LLC / initiated 2022-07-20 / Open, Classified / root cause: manufacturing process

FDA source

Alcor Scientific, Inc. began a 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 reading chamber, and to... on 2022-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1751-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-20
Posted: 2022-09-16
Recalling firm: Alcor Scientific LLC
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
Product code: GKB Device, Automated Sedimentation Rate
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Alcor Scientific notified consignees via Emails on 21 July 2022 that included an Advisory Notice (AN-001). Letter states reason for recall, health risk and action to take: " Remove from your inventory any Lot 4/22 Primary Pump Tubing Spare Part Kits (112-13-002). Destroy this tubing. " If the tubing has been installed on any iSED ESR Analyzers, the tubing must be immediately replaced with new Primary Pump Tubing (112-13-002) from any other lot and Alcor must be notified of the locations where that tubing was installed. " Complete this form and return via email to [email protected] within 3 days. ALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.
Quantity in commerce: 38 units
Distribution: US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea
Product codes and lots: Lot 4/22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1751-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1751-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15

Product code GKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)