FDA Device recall Z-2884-2016
DRI Salicylate Serum Tox Assay, Catalog number 0977
- FDA Device
- Class II
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class II recall of DRI Salicylate Serum Tox Assay, Catalog number 0977 by Microgenics, citing some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2884-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-25 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microgenics |
| Distribution | US |
Product
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Reason
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Identifiers
| code_info | Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018. |
|---|
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-2884-2016%22
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