REV 2 Flowcell Capsule Spare Recalled for Potential Rust and Erroneous Results
Beckman Coulter recalled the REV 2 Flowcell Capsule Spare due to potential rust in the cannula component, which could generate erroneous test results.
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 for a medical device component. This is a risk-of-harm product where erroneous test results could impact diagnostic accuracy and patient care. No illnesses or injuries have been reported and the hazard is theoretical (potential rust causing potential erroneous results). Per the severity rubric, this fits the High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc., is recalling the REV 2 Flowcell Capsule Spare, Part Number C04154, a component used in the Flowcell and iQClear Rinse Waste Well Assembly.
The cannula in the recalled spare parts may rust. Rust from the cannula has the potential to generate erroneous test results, affecting the accuracy of laboratory testing performed with this equipment.
The recalled units were distributed in the United States and internationally, including Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, and the United Kingdom. All lot numbers of this product are included in the recall.
The recalled product
- Product
- REV 2 Flowcell Capsule Spare, Part Number: C04154
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- rust
- erroneous-results
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 (2)
- UDI/DI15099590689452
- All lot numbers
Distribution
Distribution scope not specified by the agency.
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