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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 38
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
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