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.
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: 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)…
- 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.
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