Calibrite 340486Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903404865), received between Dec 22, 2020 and Feb 1, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2021Low Readings; Low Readings

  IT WAS REPORTED WHILE TESTING WITH BD CALIBRITE¿ 3 BEADS THERE WAS A POOR FL3 PERFORMANCE. CONFIRMATORY TESTING PERFORMED RUNNING TEST SIMULTANEOUSLY ON TO RULE OUT MACHINE ISSUE. NEW LOT OF BEADS PASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NATURE OF INCIDENT: POOR FL3 PERFORMANCE. THE AFFECTED CALIBRITE BEAD LOT NUMBER IS 0002577. TESTED SAME CALIBRITE BEAD ON 2 UNIT FACSCALIBUR SIMULTANEOUSLY (MACHINE A & MACHINE B) TO RULE OUT MACHINE PROBLEM. RUN FACSCOMP USING DIFFERENT LOT OF CALIBRITE BEAD #0212458 AND IT SHOW PASS.

  Patient problems: No Patient Involvement

  MAUDE report 11259331 ↗
• MalfunctionJan 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING WITH BD CALIBRITE¿ 3 BEADS ERRONEOUS RESULTS OCCURRED WITH PATIENT SAMPLES. COMPENSATION WAS PERFORMED WITH ALL 5 CALIBRITE BOXES AND THE FL3 SEPARATION WAS 120 OR LESS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FOR SOME TIME WE HAVE BEEN HAVING PROBLEMS WITH THE AUTOMATIC ANALYSIS OF THE MULTISET, SINCE WE OFTEN HAD TO DO THE MANUAL ANALYSIS CORRECTING THE GATE OF BEADS SINCE THEY WERE NOT TAKEN IN THEIR ENTIRETY. IN THIS LAST WEEK, ALL THE SAMPLES HAD TO BE CORRECTED SO THAT THE GATE TAKES ALL THE BEADS ACQUIRED IN THE SAMPLE AND THE PROGRAM ASKED US TO ACQUIRE MORE EVENTS (ONCE OR TWICE IN EACH SAMPLE). ALL THE CALIBRITE (5 BOXES) THAT WE HAVE TO MAKE THE COMPENSATION ARE FROM LOT N °: 9277450 WITH AN EXPIRATION DATE OF 02/28/2021. ON THE CURRENT DAY, COMPENSATION WAS MADE WITH ALL CALIBRITE BOXES AND THE FL3 SEPARATION WAS 120 OR LESS. FOR THIS REASON, WE MAKE A CLAIM FOR THIS BATCH OF CALIBRITE AND FOR THE INCONVENIENCE WE HAVE IN THE AUTOMATIC ACQUISITION OF SAMPLES TO PERFORM THE CD4 COUNT. ARE THEY USING PATIENT SAMPLE? YES. WAS THE PATIENT TREATED BASED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11244547 ↗
• MalfunctionJan 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD CALIBRITE 3 BEADS ERRONEOUS RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAIL OF THE PROBLEM: AFTER A COMPLAINT FROM THE USER DUE TO A MALFUNCTION OF THE EQUIPMENT, A BD ENGINEER IDENTIFIED THE FOLLOWING PROBLEM: ¨ THESE BATCHES CREATE FAULTY SETTINGS THAT GENERATE PROBLEMS WHEN PASSING SAMPLES (MANY MORE EVENTS THAN USUAL ARE REQUIRED AND POPULATIONS FALL OUTSIDE OF THE GATES PRESET IN MULTISET) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11165540 ↗
• MalfunctionDec 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD CALIBRITE¿ 3 BEADS THERE WAS A FAILURE FOR FL3. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: IN ALL CASES WE OBTAIN FAILURE RESULT FOR FL3.

  Patient problems: No Patient Involvement

  MAUDE report 11098731 ↗
• MalfunctionDec 22, 2020Low Readings; Low Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS ON PATIENT SAMPLES WITH BD CALIBRITE¿ 3 BEADS. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COULD YOU PLEASE PROVIDE THE BEADS MATERIAL # ? REAGENT USED; 340486 - CALIBRITE 3 COLOR BEADS KIT 25 TESTS IVD , BATCH: 0097191, 340487 - CALIBRITE APC BEADS 25 TESTS IVD, BATCH: 830480, 340487 - CALIBRITE APC BEADS 25 TESTS IVD, BATCH: 92679. EDIONE REIS : 2020-12-09 11:13:58 (GMT): IN A NEW TELEPHONE CONTACT TO MONITOR THE CASE, HE WAS INFORMED BY THE LABORATORY THAT THE PROBLEMS WERE NOT REPEATED, THE ROUTINE REMAINS NORMAL. EDIONE REIS : 2020-12-08 17:09:58 (GMT): THE CLIENT WAS ASKED FOR NEW FILES TO CONTINUE THE INVESTIGATION. ROSMARY PENAFIEL,DEC 03,2020: FACSCOMP REPORT ATTACHED. 342975 - FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD - SERIAL NUMBER: (B)(6). EDIONE REIS : 2020-11-25 18:57:50 (GMT): CUSTOMER REPORTS THAT COMPENSATION MADE WITH CALIBRITE (340486 - CALIBRITE 3 COLOR BEADS KIT 25 TESTS IVD , BATCH: 0097191 ) IS NOT PASSING WHEN USING THE APC REAGENT (340487 - CALIBRITE APC BEADS 25 TESTS IVD, BATCH: 830480). THE SAME CALIBRITE, COMBINED WITH ANOTHER APC

  Patient problems: No Patient Involvement

  MAUDE report 11060477 ↗