The Access Cortisol assay is a paramagnetic recall
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human…
Why was The Access Cortisol assay is a paramagnetic recalled?
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 15099590231118, all lots
- Product
- The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human…
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 149 units
- Distribution
- Worldwide distribution.
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)