Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues
Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.
What this means for you
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 involves a medical device reagent that may exceed calibration limits, posing a risk of inaccurate potassium measurements. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the ISE Electrolyte Reference reagent (Part No. A28937, A28945, 467935, 467915) used with Synchron LX Systems and UniCel DxC 600/800 Systems. The recall involves 718 units total, with 132 units distributed in the United States. The product is intended for the quantitative determination of potassium concentration in human serum, plasma, or urine.
The recall was initiated because the reagent has a potassium (K) response near the instrument calibration flag limits and may exceed these limits on some instruments. This issue could affect the accuracy of potassium measurements performed using the affected equipment.
The affected product was distributed worldwide, including in the United States, Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom. Users of the affected systems should contact Beckman Coulter for further instructions on how to proceed.
The recalled product
- Product
- ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCe
- 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)
- Lot No. T006042
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · inaccurate measurement
See all →- ModerateFujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
FDA (Devices) · 2026-09-02
- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- High3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
FDA (Devices) · 2026-07-29
- HighOral thermometer probes recalled after being programmed with rectal configuration
FDA (Devices) · 2025-10-29
- HighUltrasound systems recalled over inaccurate liver steatosis measurement values
FDA (Devices) · 2025-10-22