iSED Tubing Spare Part Recalled for Potential Biohazard Leak Risk
Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kits due to potential biohazard leak from the Probe Tube when installed on the iSED ESR Analyzer. Affected lot (4/22) includes 38 units distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a potential biohazard leak from a medical device component. The source text explicitly states 'potential' with no reported illnesses or injuries, making this a theoretical risk-of-harm scenario that meets the High severity threshold per the rubric.
Plain-English summary
Alcor Scientific, Inc. is recalling iSED Primary Pump Tubing Spare Part Kits (Model PN: 112-13-002, Lot 4/22) used with the iSED Automated ESR Analyzer. The tubing component is designed to move sample and wash solution from the aspiration needle through the reading chamber and to the waste.
The recalled spare parts are incorrect. When installed onto an iSED ESR Analyzer, there is a potential for a biohazard leak from the Probe Tube, which could result in exposure to biological hazard material.
The affected spare part kit affects 38 units distributed nationwide in Florida, Massachusetts, Maryland, Pennsylvania, South Dakota, and Wisconsin, as well as internationally to Croatia, Honduras, and Korea.
The recalled product
- 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
- Manufacturer
- Alcor Scientific, Inc.
- Hazard
- biohazard-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 4/22
Distribution
Distributed nationwide across the United States.
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