BD SurePath™ Manual Method Kit 491266Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904912666), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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.

• MalfunctionMar 29, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHILE TESTING WITH BD SUREPATH MANUAL METHOD KIT A SLIDE WAS MANUALLY MADE THAT DID NOT CONTAIN PATHOLOGICAL CELLS CONSISTENT WITH THE PREVIOUS CLINICAL FINDINGS. ANOTHER SLIDE WAS MADE USING THE SAME VIAL BUT WITH ANOTHER METHOD AND THE SLIDE CONTAINED THE PATHOLOGICAL CELLS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005993 ↗

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-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-1812-2012 · Mar 22, 2012 · Terminated
  PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
• 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-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-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-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