Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.
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: The recall involves a high-risk medical device where a software defect could lead to incorrect patient identification and result association, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the iQ200 Series Urine Microscopy Analyzer, including various catalog numbers such as 700-3345 and 700-3375. The device is used to automate the complete urinalysis profile, including urine test strip chemistry and microscopic sediment analysis.
The recall was initiated after customers reported incidents where two sets of results reported the same Specimen Identifier (Specimen ID) but contained different results, different Medical Record Numbers (MRN), and different patient demographics. This error could lead to incorrect patient identification and result association.
Approximately 6,601 devices were distributed worldwide. The source text does not specify specific actions for consumers or healthcare facilities, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 6,601
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 (5)
- UDI: 10837461001317
- 10837461001355
- 10837461001256
- 10837461001300
- All Part Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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.
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