Roche recalls URISYS 1100 urine analyzers with specific part numbers due to potential false negatives for protein, nitrite, leukocytes, and erythrocytes. Affected units may not detect these substances correctly.
Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters
Roche is recalling its URISYS 1100 urine analyzers with part number 03617556001 because they may give false negative results for protein, nitrite, leukocytes, and erythrocytes. This means the device might miss these substances in urine tests, which could lead to incorrect health conclusions.
The device may produce false negative results for protein, nitrite, leukocytes, and erythrocytes when using certain test strips. This happens because the limits of detection for these substances are higher than what's listed in the test strip method sheets, meaning the analyzer might not detect these substances correctly.
People who use the Roche URISYS 1100 urine analyzer for home testing with specific part numbers are affected. Those who rely on accurate urine test results for health monitoring are most at risk.
Check the product's part number, which is 03617556001. The affected units are the URISYS 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, or Chemstrip 10 UA test strips.
Verify the part number is 03617556001 to confirm if your device is affected.
The URISYS 1100 urine analyzer may give false negative results for protein, nitrite, leukocytes, and erythrocytes due to higher limits of detection than listed in the test strip method sheets.
The recall record does not specify a remedy, so there is no action required beyond checking if your device has the part number 03617556001.
Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips with the URISYS 1100 urine analyzer are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0301-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-0301-2019 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.
