[Recalled] Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine. — Beckman Coulter has identified the following dr
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine. |
|---|---|
| Brand / manufacturer | Beckman Coulter Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2080-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 April 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false 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.