Agency classClass IIOur severity:High FDA (Devices)·Z-0785-2024·Announced 2024-01-31

Beckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors

Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic 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: FDA Class II diagnostic device recall where equipment malfunction could result in erroneous results and potential misdiagnosis, but no illnesses or injuries have been reported. This fits the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Beckman Coulter, Inc. is recalling 112 units of iQ200 Series Urine Microscopy Analyzers. The affected units have part numbers 700-3320, 700-3370, 700-3345, 700-3347, C10683, 700-3375, 700-3325, and C10684.

The cannula, which is located in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results in urine analysis.

These units were distributed in the United States and internationally 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. Users should contact Beckman Coulter for information about remedy options.

The recalled product

Product: iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
Manufacturer: Beckman Coulter, Inc.
Category: Medical Device — Laboratory Diagnostics
Hazard: rust
erroneous-results
Affected units: 112

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 (16)

a) 700-3320
UDI/DI 10837461001188
b) 700-3370
UDI/DI 10837461001324
c) 700-3345
UDI/DI 10837461001300
d) 700-3347
UDI/DI 10837461001317
e) C10683
UDI/DI 15099590697129 f) 700-3375
UDI/DI 10837461001355
g) 700-3325
UDI/DI 10837461001256
h) C10684
UDI/DI 15099590695484
All serial 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 →

Same manufacturer · Beckman Coulter, Inc.

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Same hazard · rust