Cobas u 601 urinalysis analyzer recalled for false negative nitrite results
Roche Diagnostics is recalling the Cobas u 601 urinalysis test system due to potential false negative nitrite results when endogenous creatinine levels exceed 15,000 mg/L. The device may fail to detect nitrite in urine samples with elevated creatinine.
- Product
- Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intend
- Category
- Medical Device
- Distribution
- Distributed nationwide