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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a potential for false negative test results. Under the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Cobas u 601 urinalysis test system nationwide. This fully automated system is used for in vitro qualitative or semi-quantitative determination of multiple urine analytes including nitrite. Approximately 636 units are distributed in the United States.
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of nitrite results was observed at creatinine levels up to 9,000 mg/L. This means the device may fail to detect nitrite in samples with very high creatinine levels, potentially producing inaccurate test results.
The recalled product
- 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
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 636
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 04015630932252
Distribution
Distributed nationwide across the United States.
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