iQ200 Select/Elite Pro (NA)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K022774); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 19, 2023Class IIOpen, Classified

   Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

   Z-0785-2024 · Root cause: Other · Recall details · FDA record ↗

2. Apr 5, 2023Class IIOpen, Classified

   Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.

   Z-1596-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 28, 2019Class IITerminated

   Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

   Z-0914-2020 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022774. One submission often covers many models, so check the product and lot details in each record.

• Z-0786-2024 · Dec 19, 2023 · Open, Classified
  REV 2 Flowcell Capsule Spare, Part Number: C04154
• Z-0787-2024 · Dec 19, 2023 · Open, Classified
  iQ Waste Well Adapter, Part Number: 700-3393
• Z-0784-2024 · Dec 19, 2023 · Open, Classified
  Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
• Z-1598-2023 · Apr 5, 2023 · Open, Classified
  DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
• Z-1597-2023 · Apr 5, 2023 · Open, Classified
  DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
• Z-1599-2023 · Apr 5, 2023 · Open, Classified
  UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
• Z-1945-2020 · Mar 30, 2020 · Terminated
  iQ200 Series Urine Microscopy Analyzer- All part numbers
• Z-1362-2018 · Mar 2, 2018 · Terminated
  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
• Z-1366-2018 · Nov 10, 2017 · Terminated
  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