BD PrepStain Slide Processor 490407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904904074), received between Jan 26, 2022 and Aug 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING INSTRUMENT PEPSTATIN TECAN US II REFURB, THE LID WAS FALLING AND WON'T STAY OPEN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TRIPATH US II - CENTRIFUGE TWO STRUT FAILURE THE AGENT ENGINEER, IS IN A HURRY TO GIVE FEEDBACK. THE CENTRIFUGE'S SUPPORT ROD FAILED, BUT DID NOT LOSE ITS SUPPORT COMPLETELY. THERE WAS NO FREE FALL, BUT A SLOW FALL WITHOUT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606959 ↗
• MalfunctionFeb 27, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT PREPSTAIN TECAN US II REFURB THAT THERE WAS CROSS-CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STAINS OFFLINE SO CELLS OUTSIDE CELL CIRCLE ARE STAINED. CUSTOMER HAS DETERMINED THAT DRIPS ON TOP OF SLIDES ARE CROSS CONTAMINATION FROM OTHER SAMPLES. CUSTOMER DOES NOT SCREEN THESE SLIDES AND REPROCESSES SAMPLE ON A DIFFERENT SLIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450239 ↗
• MalfunctionFeb 28, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE BD PREPSTAIN¿ SLIDE PROCESSOR'S CENTRIFUGE LID WOULD NOT CLOSE PROPERLY. THERE WAS NO ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CENTRIFUGE LID NOT CLOSING PROPERLY" "NOBODY WAS HURT DUE TO THIS ISSUE. YES, THE CENTRIFUGE NOW OPERATING NORMALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620831 ↗
• MalfunctionJan 26, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE BD PREPSTAIN¿ SLIDE PROCESSOR'S SPECIMEN DRIPPED OUT AND CREATED CROSS-CONTAMINATION. AS A RESULT, THE SPECIMENS HAD TO BE RERUN. THERE WAS NO INDICATION THAT THE ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REQUESTING DISPATCH DUE TO DRIPPING SPECIMEN. THERE WAS CONTAMINATION." "WERE ANY PTS TREATED BASED ON ERRONEOUS RESULTS? NO, WHEN THE CROSS CONTAMINATION WAS SEEN, THEY RERAN THE SPECIMENS. DID THE WRONG TREATMENT HARM THE PATIENT? NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359371 ↗

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-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-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-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-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-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-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