N/A 347206Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903472062), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE WITH A BD CD138 PE ON 4 PATIENT SAMPLES THE REAGENT DID NOT RELIABLY STAIN CD138 CELLS. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS REAGENT DOES NOT RELIABLY STAIN CD138+ CELLS WHICH WERE CONFIRMED POSITIVE BY IHC AND BY SUBSEQUENT TESTING WITH CLONE DL-101. THEY HAD BEEN TROUBLESHOOTING DIM STAINING WITH THIS REAGENT, AWARE THAT CD138 EXPRESSION CAN BE VARIABLE. NO ADVERSE PATIENT EVENTS ARE REPORTED. IHC WAS ALSO USED TO CONFIRM POSITIVITY AS AN ALTERNATIVE METHOD.. THE LAB HAS BEEN VALIDATING A DIFFERENT CLONE TO REPLACE THIS PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662624 ↗