The Access Cortisol Reagent — Class II medical device recall Z-2763-2019
Terminated recall by Beckman Coulter Inc., reported 2019-10-09, distributed nationwide. Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient
| Recall number | Z-2763-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-09-18 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, LT, MX, PA, RS, VN, ZA |
| Lot numbers | 831755 |
| Model numbers | 33600, 831755 |
Product
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Reason for recall
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2763-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.