Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures
Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.
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 is classified as FDA Class II. The hazard involves false patient results that can lead to delayed treatment of serious disorders, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 2,738 vials of ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, Lot M909206. This product is used in clinical laboratories for the quantitative determination of carbon dioxide in human serum or plasma to help diagnose and treat disorders associated with changes in the body's acid-base balance.
The recall was initiated because the reagent has a low pH, which may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results. These errors can lead to a delay in patient treatment. The affected units were distributed worldwide, including nationwide in the United States and in Canada, Japan, Lebanon, Saudi Arabia, and Taiwan.
Healthcare facilities and laboratories should stop using the affected reagent and contact Beckman Coulter for instructions on return or disposal. Consumers do not use this product directly, but patients may be affected if their laboratory tests were performed using this specific lot of reagent.
The recalled product
- Product
- ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,738
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 Number: M909206
Distribution
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