FDA Device recall Z-2084-2017
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Salicylate Reagent (SALY 2 x 45), Catalog No. 378194 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-2084-2017 |
| 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
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in 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-2084-2017%22
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