The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1596-2023·Announced 2023-05-24

Urine Microscopy Analyzer Software Display Defect May Prevent Contamination Detection

Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.

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 a Class II recall affecting a diagnostic device with a software defect that could prevent detection of sample contamination. No illnesses or injuries have been reported. Per the rubric, Class II recalls without hospitalization reports do not meet the Severe threshold. This meets the High criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Beckman Coulter, Inc. is recalling 1,068 units of its iQ200 Series Urine Microscopy Analyzer. The affected models include the iQ200 Select, iQ200 Elite, iQ200 Select 1500, and iQ200 Sprint devices running Windows 10 Software Version 8.1. These in-vitro diagnostic devices are used in clinical and diagnostic laboratories for urine analysis.

An intermittent software issue affects an optional flag labeled 'Previous Sample Had Sperm.' The flag may be enabled internally but fail to display on the analyzer screen. When the display defect occurs, laboratory personnel cannot see the flag to identify and investigate potential sample carryover from the previously analyzed specimen.

The analyzers have been distributed worldwide. This is a Class II recall from the U.S. Food and Drug Administration.

The recalled product

Product
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Laboratory Diagnostic Equipment
Hazard
Affected units
1,068

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) iQ 200 Select
  • Part Numbers C10684
  • UDI/DI 15099590695484 and 700-3345
  • UD/DI 10837461001300
  • b) iQ 200 Elite
  • Part Numbers C10683
  • UDI/DI 15099590697129 and 700-3375
  • UDI/DI 10837461001355
  • c) iQ200 Select 1500
  • Part Number 700-3347
  • UD/DI 10837461001317
  • d) iQ200 Sprint
  • Part Number 700-3325
  • UDI/DI 10837461001256
  • All analyzers with Windows 10
  • Software Version 8.1

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 →

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