iQ Waste Well Adapter Recalled for Rust in Cannula Component
Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.
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: This is an FDA Class II medical device recall involving potential rust contamination that may generate erroneous diagnostic test results. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing it in the High severity category per the rubric criteria for risk-of-harm products without reported patient harm.
Plain-English summary
Beckman Coulter, Inc. is recalling the iQ Waste Well Adapter (Part Number 700-3393), a component used in laboratory diagnostic equipment including the Flowcell and iQClear Rinse Waste Well Assembly.
The cannula component of the adapter may develop rust, which has the potential to generate erroneous results in diagnostic testing. The recall affects all lot numbers of this part.
The product has been distributed throughout the United States and internationally, including to Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, and the United Kingdom.
Healthcare facilities and laboratories using this adapter should contact Beckman Coulter for guidance on replacement or remediation options.
The recalled product
- Product
- iQ Waste Well Adapter, Part Number: 700-3393
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 2
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/DI 15099590706180
- all lot numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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