BD PrepStain Slide Processor 490100Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00382904901004), received between Mar 23, 2021 and Mar 10, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Contamination” (9 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Device Markings/Labelling Problem

  IT WAS REPORTED AFTER USING BD PREPSTAIN SLIDE PROCESSOR, THE SERIAL NUMBER ON THE INSTRUMENT WAS A DUPLICATE TO ANOTHER INSTRUMENT IN THE SERVICE SYSTEM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557606 ↗
• MalfunctionJul 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED AFTER USING PREPSTAIN TECAN US II, THE SERIAL NUMBER ON THE INSTRUMENT WAS INCORRECT. IT WAS FOUND THAT THE SERIAL NUMBER OF THE INSTRUMENT IS A DUPLICATE SERIAL NUMBER TO ANOTHER INSTRUMENT IN THE FIELD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473405 ↗
• MalfunctionJul 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED AFTER USING PREPSTAIN TECAN US II, THE SERIAL NUMBER ON THE INSTRUMENT WAS INCORRECT. IT WAS FOUND THAT THE SERIAL NUMBER OF THE INSTRUMENT IS A DUPLICATE SERIAL NUMBER TO ANOTHER INSTRUMENT IN THE FIELD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470802 ↗
• MalfunctionAug 14, 2024Structural Problem; Structural Problem

  IT WAS REPORTED WHILE TESTING WITH BD PREPSTAIN SLIDE PROCESSOR, THE CENTRIFUGE LID WAS NOT STAYING OPEN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981876 ↗
• MalfunctionJun 11, 2024Structural Problem; Structural Problem

  IT WAS REPORTED WHILE TESTING WITH THE BD PREPSTAIN¿, THE SPRINGS FOR THE CENTRIFUGE LID WERE NO LONGER HOLDING LID UP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512245 ↗
• MalfunctionJun 11, 2024Structural Problem; Structural Problem

  IT WAS REPORTED WHILE TESTING WITH THE BD PREPSTAIN¿, THE CENTRIFUGE LID SPRINGS NO LONGER HELD THE LID OPEN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508698 ↗
• MalfunctionMay 2, 2024Contamination; Contamination

  IT WAS REPORTED WHILE TESTING WITH BD PREPSTAIN¿, PATIENT SAMPLE WAS DRIPPING OUT OF THE TRANSFER TIP LEADING TO CONTAMINATION OF ANOTHER PATIENT'S SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232678 ↗
• MalfunctionApr 2, 2024Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH THE BD PREPSTAIN¿, A PATIENT THYROID SAMPLE WAS CONTAMINATED WITH VAGINAL CELLS. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19024738 ↗
• MalfunctionOct 30, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE CENTRIFUGE LID OF THE BD PREPSTAIN¿ WOULD NOT STAY UP. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY HYDRAULIC SYSTEM IN OUR CENTRIFUGE LID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030566 ↗
• MalfunctionJul 7, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING USE OF THE BD PREPSTAIN¿, THE CENTRIFUGE LID WAS FREE FALLING. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM WAS PREVIOUS CENTRIFUGES WITHOUT PRESSURE IN THE DAMPERS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278681 ↗
• MalfunctionJun 1, 2023Contamination; Contamination

  IT WAS REPORTED THAT WILE USING BD PREPSTAIN¿ DURING STAINING PROCESS THERE WAS A PROBE TOUCHING ONE OF THE SLIDES AND CROSS-CONTAMINATION OCCURRED. SAMPLE WAS RE STAINED AND NO INJURIES OR TREATMENT CHANGE AFFECTED PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRIPATH US II - TABLET CONTAMINATION DURING THE STAINING PROCESS, THE LABORATORY PHYSICIAN IDENTIFIED ONLY 1 CASE OF CROSS-CONTAMINATED SAMPLES WHEN VIEWED UNDER THE MICROSCOPE. AFTER INVESTIGATION BY FSE, IT WAS FOUND THAT THERE WAS A PROBE TOUCHING ONE OF THE SLIDES. AFTERWARDS, THE LABORATORY PHYSICIAN RE-PREPARED THE PATIENT SAMPLE AND RE-STAINED IT, WHICH DID NOT AFFECT THE TEST RESULTS OR THE TREATMENT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039541 ↗
• MalfunctionMay 23, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING THE BD PREPSTAIN¿ THAT THERE WAS A LID ISSUE. IT HAS BEEN CONFIRMED WITH THE ENGINEER THAT BEFORE THE REPLACEMENT, THE CUSTOMER HELD THE LID WITH HIS HANDS TO AVOID FALLING, SO THE LID DID NOT FALL OFF. TRIPATH US II - CENTRIFUGE PNEUMATIC SUPPORT ROD AGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989691 ↗
• MalfunctionMay 10, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING THE BD PREPSTAIN¿ THAT THERE WAS CENTRIFUGE LID ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CENTRIFUGE LID ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904584 ↗
• MalfunctionApr 14, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD PREPSTAIN¿ HYDRAULIC RODS DO NOT HOLD UP. NO INJURIES HAVE BEEN REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRIPATH US II - CENTRIFUGE HYDRAULIC RODS WON'T HOLD UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747802 ↗
• MalfunctionFeb 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE THE BD PREPSTAIN¿ THAT THERE WAS CROSS CONTAMINATION. FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCASIONAL DRIP FROM DITI AFTER SAMPLE TRANSFER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318660 ↗
• MalfunctionMar 2, 2022Contamination; Contamination

  IT WAS REPORTED WHEN USING THE BD PREPSTAIN¿ THERE WAS CROSS CONTAMINATION. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INSTRUMENT WAS DROPPING SPECIMENS. NO WRONG RESULTS WERE REPORTED TO THE DOCTORS. NO PATIENTS WERE TREATED BASED ON THE RESULTS. SAMPLES ARE NOT BEING PROCESSED AND WORKFLOW IS NOT BEING MAINTAINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655086 ↗
• MalfunctionJan 27, 2022Structural Problem; Structural Problem

  IT HAS BEEN REPORTED THAT THE BD PREPSTAIN¿ HAS BEEN FOUND EXPERIENCING LID ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: TRIPATH US II - CENTRIFUGE LID UNSUPPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13373770 ↗
• MalfunctionDec 16, 2021Grounding Malfunction; Grounding Malfunction

  IT WAS REPORTED THAT DURING INSPECTION OF THE BD PREPSTAIN¿ THE FIELD SERVICE ENGINEER PHYSICALLY FELT RESIDUAL ELECTRICAL CURRENT WHEN TOUCHING THE DEVICE. NO INJURY, ADVERSE EVENT, OR IMPACT TO PATIENT RESULTS WAS REPORTED. THE ROOT CAUSE WAS DETERMINED TO BE A FAILURE WITHIN THE CUSTOMER¿S POWER OUTLET, AND THE SERVICE WAS HALTED UNTIL THE FACILITY COULD CORRECT THE ELECTRICAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022084 ↗
• MalfunctionDec 6, 2021Contamination; Contamination

  IT WAS REPORTED WHILE TESTING WITH BD PREPSTAIN¿, CONTAMINATION WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION ON SLIDES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937197 ↗
• MalfunctionOct 26, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD PREPSTAIN¿ CONTAMINATION 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: " 490100 - INSTRUMENT PREPSTAIN TECAN US II - CONTAMINATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700712 ↗
• MalfunctionSep 2, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD PREPSTAIN¿ FUNGAL CONTAMINATION HAS BEEN OCCURRING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTS THAT THEY HAVE BEEN EXPERIENCING FUNGAL CONTAMINATION BUT CANNOT DETERMINE WHICH PREPSTAIN INSTRUMENT IS RESPONSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414978 ↗
• MalfunctionMay 7, 2021Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PREPSTAIN¿ CROSS CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS. 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: " 1. CUSTOMER PROBLEM: CUSTOMER REPORTS CONFIRMED NON-GYN CROSS CONTAMINATION OCCURRED ON TRAY 2 POSITIONS 2 AND 6. 2. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER REVIEWED SLIDES AFTER PROCESSING AND NOTICED THE CROSS CONTAMINATION OCCURRED WITH POS 2 (BRONC SPECIMEN) AND 6 (NECK SPECIMEN). CUSTOMER CONFIRMED BY RE-RUNNING THOSE SPECIMENS WITHOUT A CROSS CONTAMINATION ISSUE. CUSTOMER DID NOTICE IN THE FIRST RUN THAT THE LIQUID IN THOSE POSITIONS WAS HIGHER. THE CUSTOMER HAS SINCE PERFORMED 3 OR MORE RUNS WITHOUT ISSUE. THE INSTRUMENT IS NOT IN ERROR. CONFIRMED WITH SUBJECT MATTER EXPERT THAT NON-GYN SPECIMENS ARE THICKER AND THE PIPETTE LIKELY BECAME CLOGGED IN THOSE POSITIONS. THIS WOULD EXPLAIN WHY THE LIQUID LEVEL WERE HIGHER. IN ADDITION, THIS WOULD EXPLAIN HOW THE CROSS CONTAMINATION OCCURRED AS THE PIPETTE COULD NOT FULLY ASPIRATE DUE TO SPECIMEN CLOG CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795096 ↗
• MalfunctionMar 25, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD PREPSTAIN¿ CROSS CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572693 ↗
• MalfunctionMar 23, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT WHILE USING BD PREPSTAIN¿ CROSS-CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558544 ↗

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-1812-2012 · Mar 22, 2012 · Terminated
  PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
• Z-1814-2012 · Mar 22, 2012 · Terminated
  Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
• 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-1811-2012 · Mar 22, 2012 · Terminated
  PrepStain Syringing Pipettes 240 (Catalog #490517)
• 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-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-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