BD FACSCalibur 342976Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903429769), received between May 13, 2020 and Jul 6, 2020 — 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 16, 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.

• MalfunctionJul 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS ON PATIENT SAMPLES WITH A BD FACS CALLIBUR¿ FLOW CYTOMETER W/SORTING OPTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FACSCALIBUR INSTRUMENTS CD8 AND CD19 (ANTIBODY KITS) ARE NOT DIVIDED INTO GROUPS. 2. PLACEMENT: CELL ROOM, CLINICAL USE. ADDITIONALLY, ON 2020-06-11 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CONDUCTED A REPEAT/DIFFERENT TEST TO CONFIRM THE RESULTS, THE PROBLEM REMAINS. THERE WAS NO IMPACT TO PATIENT SAMPLES AND NO PHYSICAL HARM/INJURY DUE TO THE ISSUE. NO INCORRECT RESULTS BEEN OBTAINED OR USED. NO DELAY OR ALTERCATION OF TREATMENT DUE TO THIS PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10236337 ↗
• MalfunctionMay 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE ERRONEOUS RESULTS WERE OBTAINED WITH PATIENTS SAMPLE DURING CLINICAL USE WITH A BD FACS CALLIBUR¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FACSCALIBUR ABSOLUTE TECHNICAL RESULT ABNORMAL. REPEATED TEST AND DIFFERENCE TEST WERE CONDUCTED, BUT THE PROBLEM REMAINED. WITHOUT USING THIS ABNORMAL RESULT, THE PATIENT'S TREATMENT PLAN WAS NOT AFFECTED. THE CLINICAL PATIENT SAMPLE, AND THE ON-SITE MAINTENANCE FEE IS (B)(6). CLINICAL USE. CUSTOMER CONDUCTED A REPEAT/DIFFERENT TEST TO CONFIRM THE RESULTS, THE PROBLEM REMAINS. THERE WAS NO IMPACT TO PATIENT SAMPLES AND NO PHYSICAL HARM/INJURY DUE TO THE ISSUE. NO INCORRECT RESULTS BEEN OBTAINED OR USED. NO DELAY OR ALTERCATION OF TREATMENT DUE TO THIS PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051643 ↗