FDA Device recall Z-1931-2016
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate…
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate… by Beckman Coulter, citing beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1931-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-13 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
Reason
Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.
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-1931-2016%22
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