BD PrepMate™ Automated Accessory 491103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904911034), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD PREPSTAIN¿ IT FAILED TO PUNCTURE FOUR SUREPATH VIALS. AS A RESULT, THE CUSTOMER GOT THREE SLIDES WITH NO CELLS AN ONE SLIDE WITH CELLS. THE CUSTOMER REPORTS THAT FOUR SLIDES SHOULD BE BLANK, BUT ONE OF THE FOUR SLIDES HAS CELLS. CUSTOMER ALSO REPORTS THERE ARE 40 CELLS ON MULTIPLE 10X FOVS AND IS CONCERNED OF POSSIBLE CROSS CONTAMINATION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THE PREPMATE FAILED TO PUNCTURE 4 SUREPATH VIALS. AS A RESULT, THEY GOT 3 SLIDES WITH NO CELLS AND ONE SLIDE WITH CELLS. - CUSTOMER REPORTS 4 SLIDES SHOULD BE BLANK, BUT ONE OF THE 4 SLIDES HAS CELLS. - AFFECTED SLIDE: CUSTOMER REPORTS 40 CELLS ON MULTIPLE 10X FOVS AND CONCERNED OF POSSIBLE CROSS CONTAMINATION. - CUSTOMER SAYS THIS ISSUE HAPPENED ONE TIME AND MOST LIKELY CAUSED BY OPERATOR'S ERROR. - CUSTOMER CONFIRMS THEY REPORT NO ISSUES WITH CONSUMABLES OR INSTRUMENT. - CUSTOMER HAD TO GET OFF THE PHONE AND DECLINED FURTHER INVESTIGATION OR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15602299 ↗

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