BD Totalys SlidePrep 491346Recalls & reported problems
Becton, Dickinson And Company · BD Totalys SlidePrep · Class 3
Quick summary
The BD Totalys SlidePrep is an automated processor that prepares cervical cytology slides for laboratory review. Most of its 54 reports describe sample contamination — cells or specimen droplets from one patient appearing on another patient's slide — along with structural and computer problems and a few inaccurate readings. There are no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00382904913465), received between Oct 20, 2020 and Sep 21, 2026 — classified as 1 injury, 52 malfunctions.
The most frequently reported specific device problem is “Contamination” (31 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination31
- Structural Problem6
- Computer Operating System Problem5
- Incorrect, Inadequate or Imprecise Result or Readings5
- Microbial Contamination of Device2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Open or Close1
- Excessive Heating1
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Contamination
It was reported that during use of one (1) BD Totalys¿ SlidePrep, cellular contamination was observed on patient sample slides, with the potential for cross-contamination between samples. There was no health impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839339 ↗MalfunctionJul 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781954 ↗MalfunctionJul 6, 2026Contamination
IT WAS REPORTED WHILE USING BD TOTALYS SLIDEPREP, CROSS-CONTAMINATION OF ONE PATIENT SAMPLE WAS SEEN IN ANOTHER PATIENT SAMPLE SLIDE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25717284 ↗MalfunctionJun 9, 2026Computer Operating System Problem
IT WAS REPORTED AFTER USING BD TOTALYS SLIDEPREP INSTRUMENT, THERE WAS A FALSE NEGATIVE RESULT THAT OCCURRED FROM THE INSTRUMENT READING SLIDES WITH UNEVEN CELLULARITY ON SLIDES. NO ADVERSE IMPACT OR MIS-ASSOCIATION OF RESULTS WERE REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446098 ↗MalfunctionApr 2, 2026Contamination
IT WAS REPORTED WHILE USING BD TOTALYS SLIDEPREP, POTENTIAL CROSS-CONTAMINATION OF PATIENT SAMPLES WAS SEEN IN THE SAMPLE SLIDES FROM THE INSTRUMENT. THE CUSTOMER REPORTED THAT AN UNKNOWN NUMBER OF SLIDES FROM THE INSTRUMENT HAD DROPS OF SPECIMEN ON THEM BUT COULD NOT CONFIRM IF IT WAS ANOTHER PATIENT'S SPECIMEN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765990 ↗MalfunctionFeb 20, 2026Contamination
IT WAS REPORTED AFTER USING BD TOTALYS SLIDEPREP, CROSS-CONTAMINATION OF PATIENT SAMPLES WAS SEEN IN THE INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402244 ↗MalfunctionFeb 20, 2026Contamination
IT WAS REPORTED AFTER USING BD TOTALYS SLIDEPREP, CROSS-CONTAMINATION BETWEEN PATIENT SAMPLES WAS SEEN IN THE INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402227 ↗MalfunctionFeb 11, 2026Contamination
IT WAS REPORTED AFTER USING BD TOTALYS SLIDEPREP, CROSS-CONTAMINATION WAS SEEN IN THE SLIDES DUE TO A CLOG IN THE INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314926 ↗MalfunctionNov 6, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED WHILE USING BD TOTALYS SLIDEPREP, THERE WAS MIS-ASSOCIATION OF ONE PATIENT SAMPLE TO ANOTHER. THE INSTRUMENT WAS RUNNING IN THE INCORRECT MODE, AND THE SLIDE WAS MADE WITHOUT MATCHING IT TO THE CORRECT BARCODE. NO ADVERSE IMPACT OR RESULTS WERE REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485855 ↗MalfunctionOct 28, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED WHILE USING BD TOTALYS SLIDEPREP, IT WAS DISCOVERED WHILE PERFORMING THE PRODUCT INVESTIGATION THAT THE USER EXPERIENCED A BURN TO THEIR FINGER WHEN PULLING OUT THE SLIDE TRAY DUE TO A HEATER ERROR. THE USER EXPERIENCED REDNESS IN THE FINGER, BUT THE CONDITION CALMED DAYS LATER AND USER WAS ABLE TO RECOVER FULLY WITHOUT TREATMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406542 ↗MalfunctionAug 28, 2025Contamination; Contamination
IT WAS REPORTED AFTER USING BD TOTALYS SLIDEPREP, CROSS-CONTAMINATION OF PATIENT SAMPLES WAS SEEN IN THE SAMPLE/INSTRUMENT. THE INSTRUMENT'S QUAD BUNDLE TOUCHES THE SLIDES, LEADING TO CROSS-CONTAMINATION ON THE SLIDES. NO CONTAMINATION SPREAD THROUGHOUT THE INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916511 ↗MalfunctionAug 14, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT WHILE USING BD TOTALYS SLIDEPREP, THERE WAS A LID/LATCH FAILURE ON THE CONNECTED HETTICH CENTRIFUGE BEFORE USE. THE LID COULD NOT STAY OPEN ON ITS OWN AND WAS FREE-FALLING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803825 ↗MalfunctionAug 7, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED WHILE USING BD TOTALYS SLIDEPREP THERE WAS POSSIBLE MIS-ASSOCIATION OF 7 PATIENT SAMPLES. THE CELLS ON THE SLIDES FOR 7 SPECIMENS DID NOT MATCH THE TYPE OF SPECIMEN COLLECTION SOURCE FOR THOSE PATIENTS. THE SAMPLES WERE RETESTED FROM THE ORIGINAL SPECIMEN CONTAINER AND THE SAMPLES RAN AS EXPECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742908 ↗MalfunctionMay 30, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED AFTER USING TOTALYS SLIDEPREP CE, THERE WAS MIS-ASSOCIATION OF 1 PATIENT SAMPLE. DUE TO MIX UP OF SLIDE PREPARATION ON THE INSTRUMENT, THE PATIENT APPEARED TO BE NEGATIVE FOR MALIGNANCY BUT WAS FOUND TO BE POSITIVE FOR MALIGNANCY AFTER MANUAL CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116316 ↗MalfunctionMay 30, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED AFTER USING TOTALYS SLIDEPREP CE, THERE WAS MIS-ASSOCIATION OF 1 PATIENT SAMPLE. DUE TO MIX UP OF SLIDE PREPARATION ON THE INSTRUMENT, THE PATIENT APPEARED TO BE NEGATIVE FOR MALIGNANCY BUT WAS FOUND TO BE POSITIVE FOR MALIGNANCY AFTER MANUAL CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116312 ↗MalfunctionMay 28, 2025Contamination; Contamination
IT WAS REPORTED AFTER USING TOTALYS SLIDEPREP CE, POSSIBLE CROSS-CONTAMINATION FROM A PREVIOUS SAMPLE WAS SEEN IN THE SAMPLE/INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101087 ↗MalfunctionMar 14, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING TOTALYS SLIDEPREP CE, CROSS-CONTAMINATION OF UNKNOWN SUBSTANCE/SPECIES WAS SEEN IN THE INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21607546 ↗MalfunctionFeb 19, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING TOTALYS SLIDEPREP, CROSS-CONTAMINATION OF UNKNOWN WAS SUSPECTED ON THE SLIDE AFTER USING THE INSTRUMENT. NO FURTHER INFORMATION WAS GIVEN IN THE DESCRIPTION TO CONTAMINATION SPECIFICS, BUT ONLY THAT CONTAMINATION WAS REPORTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411495 ↗MalfunctionJan 21, 2025Contamination; Contamination
IT WAS REPORTED WHILE TESTING WITH BD TOTALYS SLIDEPREP, CONTAMINATION WAS OBSERVED ON THE SLIDES. THE CONTAMINATION POSSIBLY ORIGINATED FROM THE DI WATER BOTTLE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201270 ↗MalfunctionJan 2, 2025Contamination; Contamination
IT WAS REPORTED WHILE TESTING WITH BD TOTALYS SLIDEPREP, THERE WERE GREEN PARTICLES NOTED ON THE SLIDE. THERE WAS CONTAMINATION NOTED IN THE DI WATER BOTTLE AND POSSIBLY THE TUBING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057602 ↗MalfunctionSep 27, 2024Structural Problem; Structural Problem
IT WAS REPORTED WHEN USING THE BD TOTALS SLIDE PREP, THE SHOCKS FOR THE CENTRIFUGE LID WERE NO LONGER HOLDING THE LID OPEN. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322837 ↗MalfunctionMay 16, 2024Contamination; Contamination
IT WAS REPORTED WHILE TESTING WITH BD TOTALYS SLIDEPREP, THE DISPOSABLE TIP MECHANISM WAS SCRAPING THE SLIDES CAUSING CROSS CONTAMINATION OF THE SLIDES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19335085 ↗MalfunctionJan 12, 2024Contamination; Contamination
IT WAS REPORTED WHEN USING THE BD TOTALYS SLIDEPREP, A SEMICIRCULAR CONTAMINATED TRAJECTORY FORMED ON ONE (1) SPECIMEN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18503034 ↗MalfunctionDec 19, 2023Contamination; Contamination
IT WAS REPORTED THAT DURING USE WITH THE BD TOTALS SLIDE-PREP, THERE WAS SUSPECTED CROSS CONTAMINATION OF SAMPLES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18355304 ↗MalfunctionAug 30, 2023Contamination; Contamination
IT WAS REPORTED THAT WHILE USING BD TOTALYS SLIDEPREP, THERE WAS CROSS-CONTAMINATION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WAD TOUCHED THE GLASS, AND SOME PIECES WERE SUSPECTED OF BEING CONTAMINATED. WAS THE CONTAMINATION NOTICED PRIOR TO ANY RESULTS BEING GENERATED? >> YES. NO PATIENT IMPACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17651680 ↗
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 · TerminatedBD 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 · TerminatedPrepStain 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 · TerminatedPrepStain Installation Kit (PreCoat), Catalog/Model # 490528
- Z-1814-2012 · Mar 22, 2012 · TerminatedManual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- Z-1812-2012 · Mar 22, 2012 · TerminatedPrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
- Z-1811-2012 · Mar 22, 2012 · TerminatedPrepStain Syringing Pipettes 240 (Catalog #490517)
- Z-2087-2012 · Dec 8, 2011 · TerminatedPrepStain 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-2086-2012 · Dec 8, 2011 · TerminatedPrepStain 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-2085-2012 · Dec 8, 2011 · TerminatedPrepStain 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 · TerminatedPrepStain 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-1090-2009 · Sep 26, 2008 · TerminatedBD 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
Other Processor, Cervical Cytology Slide, Automated devices
- BD SurePath™ Collection Vial 491452Becton, Dickinson And Company · Processor, cervical cytology slide, automated82 reports
- BD PrepStain Slide Processor 490100Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated24 reports
- BD Totalys MultiProcessor 443327Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated13 reports
- BD Totalys™ MultiProcessor Consumables Kit 491453Becton, Dickinson And Company · Processor, cervical cytology slide, automated4 reports
- BD PrepStain Slide Processor 490407Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated4 reports
- BD PrepStain Slide Processor 490410Tripath Imaging, Inc. · Processor, Cervical Cytology Slide, Automated2 reports
- BD PrepStain™ Consumables Kit 491454Becton, Dickinson And Company · Processor, cervical cytology slide, automated1 report
- BD SurePath™ Preservative Fluid 491337Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.