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U.S. Department of Health and Human Services

Class 2 Device Recall Alcor

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  Class 2 Device Recall Alcor see related information
Date Initiated by Firm July 20, 2022
Create Date September 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-1751-2022
Recall Event ID 90762
Product Classification Device, automated sedimentation rate - Product Code GKB
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
Code Information Lot 4/22
Recalling Firm/
Manufacturer		 Alcor Scientific, Inc.
20 Thurber Blvd
Smithfield RI 02917-1858
For Additional Information Contact SAME
401-737-3774
Manufacturer 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
FDA Determined
Cause 2		 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 techservice@alcorscientific.com 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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