Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.
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 is classified as FDA Class II and involves a risk of delayed treatment for health conditions, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100. The recall covers 4,350 total units, including 1,713 units in the United States. The devices were distributed nationwide in the U.S., including Puerto Rico, and to numerous foreign countries.
The recall is due to a defect where the analyzer may intermittently fail to read urine sample dilution barcode labels. This failure can cause erroneous test results. Erroneous results could delay treatment for health conditions such as hematuria.
Healthcare facilities and users should contact Beckman Coulter for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044…
- Manufacturer
- Beckman Coulter Inc.
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 iQ200 Series in the field with barcode reader model NFT-2100
Distribution
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