BD PrepStain™ Consumables Kit 491454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904914547), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 16, 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.

• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED KIT PREPSTAIN CONSUME 480 TEST EXPIRATION ON OUTSIDE OF BOX WAS FURTHER OUT THAN EXPIRATION DATES ON THE INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES EXPIRATION ON OUTSIDE OF BOX WAS FURTHER OUT THAN EXPIRATION DATES ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560450 ↗

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-1811-2012 · Mar 22, 2012 · Terminated
  PrepStain Syringing Pipettes 240 (Catalog #490517)
• 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-1813-2012 · Mar 22, 2012 · Terminated
  PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
• 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-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-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-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