Chemstrip 7 Test Strips 11008552160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00075537671603), received between Apr 29, 2022 and Jun 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  THIS REPORT WAS INITIALLY PROVIDED TO ROCHE BY FDA VIA MEDWATCH (B)(4). ROCHE URINE DIPSTICK PRODUCTS ARE GIVING TRACE PROTEIN RESULTS ON A NORMAL QUALITY CONTROL. (EXPECTED RESULT IS NEGATIVE). CHEMSTRIP 7 (PRODUCT NUMBER (B)(4) ACROSS MULTIPLE LOT NUMBERS, LOCATIONS AND USERS. ALSO OBSERVED IN THE CHEMSTRIP 10, AND CHEMSTRIP 10SG PRODUCT. FDA SAFETY REPORT ID #:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676398 ↗
• MalfunctionApr 29, 2022Incorrect, Inadequate or Imprecise Result or Readings

  ROCHE URINE DIPSTICK PRODUCTS ARE GIVING TRACE PROTEIN RESULTS ON A NORMAL QUALITY CONTROL (EXPECTED RESULT IS NEGATIVE). CHEMSTRIP 7 (PRODUCT NUMBER (B)(4)) ACROSS MULTIPLE LOT NUMBERS, LOCATIONS AND USERS. ALSO OBSERVED IN THE CHEMSTRIP 10, AND CHEMSTRIP 10SG PRODUCT. FDA SAFETY REPORT ID #:(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14257493 ↗