Beckman Coulter Access Cortisol Assay Recalled for Calibration Error
Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.
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 with a defect that can lead to potential injuries, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling 149 units of the Access Cortisol assay, a paramagnetic particle, chemiluminescent immunoassay used to measure cortisol levels in human serum, plasma, and urine. The recall is due to a protocol file error that applies an incorrect calibration curve acceptance parameter at the S1 calibrator level.
This error can lead to a high rate of calibration failures, which may vary by reagent lot number. Calibration failures would result in delays in reporting measurement results and pose a risk of potential injuries to patients. The affected product is identified by UDI/DI 15099590231118 and includes all lots.
The product was distributed worldwide. Healthcare facilities and laboratories using the Access Immunoassay Systems should stop using the affected units and contact Beckman Coulter for further instructions.
The recalled product
- Product
- The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 149
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 (2)
- UDI/DI 15099590231118
- all lots
Distribution
Distribution scope not specified by the agency.
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