BD Totalys MultiProcessor 443327Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382904433277), received between Sep 3, 2021 and Jun 4, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

11 other recalls cover devices cleared under the same FDA submission (P970018); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Computer Operating System Problem

  IT WAS REPORTED AFTER USING BD TOTALYS MULTIPROCESSOR, THERE WAS MIS-ASSOCIATION OF A PATIENT NAME AND THE ACTUAL PATIENT SAMPLE NUMBER. THE CASE NUMBER ON THE SLIDE MATCHED THE CASE NUMBER ON THE VIAL CORRECTLY, BUT THE PATIENT'S NAME ON THE SLIDE DOES NOT MATCH THE NAME IN THE CUSTOMER'S LIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392344 ↗
• MalfunctionJun 4, 2026Computer Operating System Problem

  IT WAS REPORTED AFTER USING BD TOTALYS MULTIPROCESSOR, THERE WAS MIS-ASSOCIATION OF PATIENT NAME AND ACTUAL PATIENT SAMPLE NUMBER. THE CASE NUMBER ON THE SLIDE MATCHED THE CASE NUMBER ON THE VIAL CORRECTLY, BUT THE PATIENT'S NAME ON THE SLIDE DOES NOT MATCH THE NAME IN THE CUSTOMER'S LIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392321 ↗
• MalfunctionJun 4, 2026Computer Operating System Problem

  IT WAS REPORTED AFTER USING BD TOTALYS MULTIPROCESSOR, THERE WAS MIS-ASSOCIATION OF PATIENT NAME AND ACTUAL PATIENT SAMPLE NUMBER. THE CASE NUMBER ON THE SLIDE MATCHED THE CASE NUMBER ON THE VIAL CORRECTLY, BUT THE PATIENT'S NAME ON THE SLIDE DOES NOT MATCH THE NAME IN THE CUSTOMER'S LIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392320 ↗
• MalfunctionOct 27, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED WHILE USING BD TOTALYS MULTIPROCESSOR, THERE WAS A POTENTIAL MISASSOCIATION OF 1 PATIENT SAMPLE NUMBER. THE NUMBER ON THE LABEL BEING ASSIGNED TO A PATIENT SAMPLE WAS DUPLICATED FOR 2 SAMPLES, WHICH RESULTED IN ONE TYPE OF TEST ALSO BEING ADDED TO THE OLDER SAMPLE AS WELL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393208 ↗
• MalfunctionAug 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE TESTING ON BD TOTALYS MULTIPROCESSOR, THERE WAS A MISMATCH BETWEEN SAMPLE NUMBER LABELS. NO ADVERSE EVENTS OR PATIENT IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886518 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING INSTRUMENT BD TOTALYS MULTIPROCESSOR, PATIENT DATA WAS INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886508 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING INSTRUMENT BD TOTALYS MULTIPROCESSOR, PATIENT DATA WAS INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886343 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING INSTRUMENT BD TOTALYS MULTIPROCESSOR, PATIENT DATA WAS INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886320 ↗
• MalfunctionFeb 20, 2025Structural Problem; Structural Problem

  IT WAS REPORTED WHILE TESTING WITH BD TOTALYS MULTIPROCESSOR, THE CENTRIFUGE LID WAS FREE-FALLING DUE TO SPRINGS BEING WORN OUT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422317 ↗
• MalfunctionMar 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD TOTALYS MULTIPROCESSOR THE USER WAS UNABLE TO USE THE BARCODE SCANNER OF THE DEVICE THEREFORE MANUAL ENTRY OF PATIENT INFORMATION WAS REQUIRED. THE USER INADVERTENTLY ENTERED THE PATIENT INFORMATION INCORRECTLY FOR TWO PATIENTS, SWAPPING ONE FOR THE OTHER. THE ERROR WAS CAUGHT ALLOWING THE USER TO CORRECT THE ERROR. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912681 ↗
• MalfunctionAug 2, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD TOTALYS MULTIPROCESSOR THERE IS CROSS-CONTAMINATION OF THE INSTRUMENT CAUSING AN INCREASED LEUKOCYTE COUNT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOTICED THAT OUR SAMPLES GOT A LOT OF LEUKOCYTES THE LAST FEW WEEKS. THE AMOUNT OF LEUKOCYTES ON A SLIDE IS RELATED TO THE SAMPLE ITSELF. MOST OF THE LEUKOCYTES ARE REMOVED DURING THE CELL ENRICHMENT PROCESS IN THE MULTIPROCESSOR. IT DID NOT CONCERN ERRONEOUS RESULTS ¿ JUST MESSY RESULTS; OBSTRUCTED WITH UNDESIRED CELLS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440548 ↗
• MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE INSTRUMENT BD TOTALYS MULTIPROCESSOR THAT THERE WAS MIS-ASSOCIATION OF DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IF SALESFORCE PIR COMPLAINT, DATE RECEIVED: .CUSTOMER PROBLEM: THE CUSTOMER REPORTS WHEN THE CYTOLOGIST LOOKED AT 4 SLIDES THEY SAW THAT THEY WERE MISMATCHED AND WANTED TO KNOW WHY. THE CUSTOMER WANTED IT DOCUMENTED THEY HAD 4 MISMATCH SLIDES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820703 ↗
• MalfunctionSep 3, 2021Patient Data Problem; Patient Data Problem

  IT WAS REPORTED THAT WHILE USING INSTRUMENT BD TOTALYS MULTIPROCESSOR A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IN THE DATALINK, CUSTOMER FOUND TWO DIFFERENT PATIENTS ASSOCIATED WITH ONE SINGLE C-TUBE BARCODE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426019 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970018. One submission often covers many models, so check the product and lot details in each record.

• Z-0877-2017 · Feb 12, 2016 · Terminated
  BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System
• Z-1815-2012 · Mar 22, 2012 · Terminated
  PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recal
• Z-1813-2012 · Mar 22, 2012 · Terminated
  PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
• Z-1812-2012 · Mar 22, 2012 · Terminated
  PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
• Z-1811-2012 · Mar 22, 2012 · Terminated
  PrepStain Syringing Pipettes 240 (Catalog #490517)
• Z-1814-2012 · Mar 22, 2012 · Terminated
  Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
• Z-2087-2012 · Dec 8, 2011 · Terminated
  PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in t
• Z-2085-2012 · Dec 8, 2011 · Terminated
  PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use i
• Z-2088-2012 · Dec 8, 2011 · Terminated
  PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424)
• Z-2086-2012 · Dec 8, 2011 · Terminated
  PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are in
• Z-1090-2009 · Sep 26, 2008 · Terminated
  BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05