BIO-FLASH 3710-0344Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950639725), received between Dec 27, 2024 and Dec 27, 2024 — classified as 1 injury.

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

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 16, 2026.

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.

• InjuryDec 27, 2024False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

  THE QUANTA FLASH® GBM IS A CHEMILUMINESCENT IMMUNOASSAY (CIA) FOR THE SEMI-QUANTITATIVE DETECTION OF IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) AUTOANTIBODIES IN HUMAN SERUM ON THE BIO-FLASH® INSTRUMENT. QUANTA FLASH® GBM IS AN AID IN THE DIAGNOSIS OF GOODPASTURE'S SYNDROME IN CONJUNCTION WITH CLINICAL FINDINGS AND OTHER LABORATORY TESTS. COMPLAINT (B)(4) REPORTED THAT A PATIENT WITH ACUTE KIDNEY INJURY PRESENTED WITH A NEGATIVE QUANTA FLASH GBM REAGENT (LOT NUMBER 244154) RESULT ON (B)(6) 2024. ON (B)(6) 2024 THE SAMPLE WAS RETESTED USING THE PHADIA MPO AND PR-3 ASSAYS, WHICH TESTED LOW POSITIVE FOR MPO AND NEGATIVE FOR PR-3. A BIOPSY WAS ORDERED (DATE UNKNOWN) BASED UPON THE PHADIA LOW POSITIVE MPO TEST RESULT. THE BIOPSY WAS POSITIVE FOR IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) DISEASE. PLEX TREATMENT (PLASMA EXCHANGE) WAS ADMINISTERED FOLLOWING THE BIOPSY RESULTS. HOWEVER, THE CUSTOMER REPORTED THAT THE DELAY IN DIAGNOSIS LED TO IRREVERSIBLE DESTRUCTION OF ORGAN AND PERMANENT NEED FOR DIALYSIS.

  Patient problems: Kidney injury

  MAUDE report 21031210 ↗