FACS 335775Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903357758), received between Jun 30, 2020 and May 8, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

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. Jun 3, 2025Open, Classified

   Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

   Z-2078-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS CONTAMINATION WAS OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILING LOT". "1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. YES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. YES. IF NO, NO FURTHER QUESTIONS REQUIRED. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988548 ↗
• MalfunctionNov 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS THAT THE LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870415 ↗
• MalfunctionOct 4, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS BD 7 COLOR SETUP BEADS DON¿T HAVE A LINE ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IT WAS REPORTED BY THE CUSTOMER THAT BD 7 COLOR SETUP BEADS DON¿T HAVE A LINE ON THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536667 ↗
• MalfunctionJun 30, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SETUP TUBE WAS NOT LABELED DURING USE WITH A BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOVERED A 7-COLOR SETUP TUBE WHICH WASN¿T LABELED. THE BEAD PELLET WAS THERE, BUT THERE WERE NO EVENTS SEEN DURING SETUP. HE TRIED ANOTHER TUBE AND THIS WAS OK. ADDITIONALLY, ON 2020-06-22 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED THE TUBE AFTER IT WAS EXPIRED, HE WAS AWARE OF THIS AND HE DIDN¿T CARE.

  Patient problems: No Patient Involvement

  MAUDE report 10213033 ↗