FDA Device recall Z-3006-2020
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570 by Beckman Coulter, citing due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3006-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-26 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Reason
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Identifiers
| code_info | Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3006-2020%22
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