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Access Ostase QC

by Beckman Coulter Inc.

Ref 37309

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232904↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK232904 Date15 Apr 2024IssuedStatusActive
European UnionCE/IVDR EUDAMED Number150995901AccOstQCXR Basic UDI-DI Date2 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590232290 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · FDA

    • Terminated Z-1239-2012 FDA Unclassified (pre-2012) initiated 10 Nov 2011

    The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.

    • Terminated Z-2606-2011 FDA Unclassified (pre-2012) initiated 10 May 2011

    The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
37309
Primary DI / UDI-DI
15099590232290, 15099590816988
Basic UDI-DI
150995901AccOstQCXR, 150995909AccOstQC5L
FDA Product Code
JJX
EMDN Code
W0102152099 Controls- immunochemistry - other
GMDN Term
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
862.1660
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No