FDA Device recall Z-1024-2015
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 by Beckman Coulter, citing N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OS….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1024-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-15 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Reason
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1024-2015%22
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