The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of
FDA device recall Z-0313-2025 · posted 2024-11-06 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- 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.
- Action taken
- Beckman Coulter issue and URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2024 via letter (USPS) and email. The notice explained the issue, the impact to the patient, and requested the use of alternative lot of Access Cortisol reagent. In the event the laboratory cannot generate a passing calibration curve use alternative methodology including alternative Beckman Coulter Access Immunoassay Systems. Beckman Coulter will release an updated Access Cortisol APF on the DxI 9000 Access Immunoassay Analyzer that includes the correct calibration curve acceptance parameter at the S1 calibrator level. A Beckman Coulter representative will contact you when the updated APF is available. The notice is to be shared with laboratory staff and forwarded to all parties to whom the the affected product was distributed.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- CGR
- Quantity affected
- 149 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-09-30
- Date posted
- 2024-11-06
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access Cortisol (K223038) | Beckman Coulter, Inc. | 2023-02-08 |