Roche recalls Cobas U 601 urinalysis test systems with potential false negative nitrite results at high creatinine levels. Affected units may require testing adjustments.
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.
Roche is recalling its Cobas U 601 urinalysis test systems due to a risk of false negative nitrite results when creatinine levels exceed 15,000 mg/L. This could lead to missed diagnoses of urinary tract infections or other conditions.
The test system may produce false negative nitrite results when creatinine levels in urine are 15,000 mg/L or higher. At lower creatinine levels (up to 9,000 mg/L), the test works normally without interference.
Users of the Cobas U 601 urinalysis test system, particularly those with high creatinine levels in their urine, may experience false negative nitrite results. Patients with kidney issues or those using the system for frequent urinalysis testing are at higher risk.
Check for the Cobas U 601 urinalysis test system with catalog number 06334601001. The product includes the cobas u 601 urine analyzer and cobas u pack. The unique device identifier (UDI) is 04015630932252.
Verify the catalog number 06334601001 and unique device identifier (UDI) 04015630932252 to confirm if your unit is affected.
The recall is due to a potential risk of false negative nitrite results when creatinine levels in urine exceed 15,000 mg/L.
If you have high creatinine levels in your urine (15,000 mg/L or higher), the test may show a false negative for nitrite, potentially missing a urinary tract infection.
The official recall does not provide a fix; users should check if their unit is affected and consider alternative testing methods if needed.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0266-2022 — Roche Roche Hello, I own a Roche that is covered by recall Z-0266-2022 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
