[Recalled] Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 — N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for th… | FDA 2014-12-15
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 |
|---|---|
| Brand / manufacturer | Beckman Coulter Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1024-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 December 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.