OFFICIAL-SOURCE RECALL · AUSTRALIA
iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. An in vitro Recall: Classification Class II Reason
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- iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. An in vitro diagnostic medical device (IVD).
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Why this product was recalled
Classification Class II Reason for the Action Beckman Coulter has received customer complaints about lamina fluid leaks in iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. Investigation determined that the leaks are caused by a check valve in the rinse line becoming structurally compromised. This may allow lamina fluid to migrate to internal instrument surfaces and eventually leak onto the table surface and/or floor. Potential health consequences include slip and fall hazards, which may result in bruises, sprains, fractures, head injury, or musculoskeletal trauma, and chemical exposure, which may cause minor eye irritation. Instructions for Customers/Users Customers are to: - Perform the daily Cleaning Instrument Surfaces maintenance described in Chapter 12, Maintenance Procedure of the DxU 840/850m or iQ200 IFU. During the cleaning, inspect the instrument for signs of lamina leakage, including fluid accumulation on or around the instrument, or evidence of fluid on the laboratory bench or floor. If there is a leak, discontinue use and clean any spilled fluid in accordance with the laboratory’s safety procedure. -
Hazard
Classification Class II Reason for the Action Beckman Coulter has received customer complaints about lamina fluid leaks in iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. Investigation determined that the leaks are caused by a check valve in the rinse line becoming structurally compromised. This may allow lamina fluid to migrate to internal instrument surfaces and eventually leak onto the table surface and/or floor. Potential health consequences include slip and fall hazards, which may result in bruises, sprains, fractures, head injury, or musculoskeletal trauma, and chemical exposure, which may cause minor eye irritation. Instructions for Customers/Users Customers are to: - Perform the daily Cleaning Instrument Surfaces maintenance described in Chapter 12, Maintenance Procedure of the DxU 840/850m or iQ200 IFU. During the cleaning, inspect the instrument for signs of lamina leakage, including fluid accumulation on or around the instrument, or evidence of fluid on the laboratory bench or floor. If there is a leak, discontinue use and clean any spilled fluid in accordance with the laboratory’s safety procedure. -
Official recall notice
iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. An in vitro diagnostic medical device (IVD).
Agency: Therapeutic Goods Administration
Official publication date: August 18, 2026
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