FDA Device recall Z-2082-2017
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625 by Beckman Coulter, citing beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2082-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-03 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
Reason
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2082-2017%22
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