Clearview® 92002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815845020024), received between Jun 1, 2018 and Jun 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 30, 2025Open, Classified

   Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.

   Z-2337-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, THE PATIENT PRESENTED AT THE URGENT CARE FACILITY WITH A SORE THROAT. UPON THE INITIAL EXAMINATION, THE CUSTOMER NOTED THAT THE PATIENT'S THROAT ONLY APPEARED A LITTLE RED AND IT WAS NOT IMMEDIATELY EVIDENT THE PATIENT HAD STREP A. A TEST WAS PERFORMED WITH A CLEARVIEW STREP A EXACT II DIPSTICK TEST USING A DUAL SWAB TECHNIQUE AND A NEGATIVE RESULT WAS OBTAINED AT THE 5 MINUTE READ TIME. THE SECOND THROAT SWAB WAS SENT TO (B)(6) LABORATORY FOR CULTURE CONFIRMATION. THE PATIENT WAS DIAGNOSED WITH PHARYNGITIS AND SENT HOME. TWO HOURS AFTER TEST WAS PERFORMED ON THE CLEARVIEW STREP A EXACT II DIPSTICK TEST, THE OPERATOR NOTICED A FAINT POSITIVE LINE HAD DEVELOPED IN THE TEST REGION AND FORWARDED THIS INFORMATION TO THE CUSTOMER. ON (B)(6) 2018, THE CUSTOMER CONTACTED THE PATIENT TO INFORM THE PATIENT OF THE POSITIVE RESULT AND PRESCRIBE AMOXICILLIN. AT THIS TIME, THE THROAT CULTURE RESULTS HAD NOT BEEN RECEIVED. ON (B)(6) 2018, THE CUSTOMER OBTAINED A POSITIVE RESULT FROM THE CONFIRMATORY THROAT CULTURE. THE REPORT INDICATED THAT THERE WERE A FEW COLONIES OF STREP A ON THE CULTURE. THE CULTURE WAS PERFORMED ON STREP A SPECIFIC BACITRACIN DISK. THE CUSTOMER PROCEEDED TO

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7563182 ↗