Beckman Coulter iQ200 Urine Analyzer Recall for Under-Reporting Issue
Beckman Coulter is recalling the iQ200 Series Urine Microscopy Analyzer because it may under-report casts when certain measurement settings are used. The issue could affect test results during initial setup or after settings are changed.
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 with potential for under-reporting that could affect diagnosis, but no illnesses or injuries reported. Fits the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.
Plain-English summary
Beckman Coulter Inc. is recalling the BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, a clinical urine analysis device. The recall affects multiple catalog numbers and involves 5,247 units distributed worldwide.
The issue is a potential for under-reporting casts in urine samples. This can occur if the software is set to measure casts per high-power field (/HPF) but the abnormal threshold and grading format are configured based on reporting per low-power field (/LPF) or per microliter. This mismatch may happen during initial method validation or if settings are altered after validation.
The recall affects laboratories and healthcare facilities using this analyzer. Users should verify their software settings are consistent and contact Beckman Coulter for guidance on correcting the configuration and reviewing their method validation.
The recalled product
- Product
- BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 5,247
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)
- All
Distribution
Distribution scope not specified by the agency.
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