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SurePath

by Becton, Dickinson and Company

Ref 491337, 491486

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

11 closed

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290GDYWNUNZHN Basic UDI-DI Date8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382904913373 UDI-DI Date8 Sep 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

11 recalls · FDA

    • Terminated Z-0877-2017 FDA Class II initiated 12 Feb 2016

    BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.

  • 5 recalls, same reason

    • Terminated Z-1815-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1813-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1811-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1814-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1812-2012 FDA Class III initiated 22 Mar 2012

    The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

  • 4 recalls, same reason

    • Terminated Z-2085-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2087-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2088-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2086-2012 FDA Class II initiated 8 Dec 2011

    Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.

    • Terminated Z-1090-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008

    Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SurePath EUDAMED
BD SurePath™ Preservative Fluid GUDID
Generic Name
Cytology fixative solution IVD
Device Name
BD SurePath™ Direct to Slide Kit, 480 BD SurePath™ Direct to Slide Kit, 96
Model / Ref / Catalog
491337, 491486
Primary DI / UDI-DI
00382904913373, 00382904914868
Basic UDI-DI
038290GDYWNUNZHN, 038290CGLIDXYL58
PMA Number
FDA Product Code
MKQ
EMDN Code
W01030705, W02029085
GMDN Term
Cytology fixative solution IVD
Device Class
Class A EUDAMED
Class III GUDID
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000018910
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Becton, Dickinson and Company

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Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No