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Analysis Client v2.2

by Exact Sciences Corporation

Analysis Client v2.2 is a Class III device made by Exact Sciences Corporation, approved under FDA PMA P230043 on 3 Oct 2024 (1 earlier submission) and listed in FDA GUDID since 19 Mar 2025 (UDI-DI 00858637005857), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P230043

+1 more

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858637005857 UDI-DI Date19 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP230043 Date3 Oct 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P230043 decided 3 Oct 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00858637005857 listed 19 Mar 2025 Listed

Recalls

1 recall · FDA

    • Terminated Z-2219-2017 FDA Class II initiated 28 Apr 2017

    Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.

Timeline

4 dated events

  1. Approved FDA PMA P130017
  2. Recall initiated FDA recalls Z-2219-2017
  3. Approved FDA PMA P230043
  4. Listed FDA GUDID 00858637005857

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Generic name
Laboratory instrument/analyser application software IVD
Model / reference
2.2
Primary DI / UDI-DI
00858637005857
PMA number
FDA product code
PHP
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laboratory instrument/analyser application software IVD

Cleared under the same submission (P130017)

and 8 more cleared under P130017

Cleared under the same submission (P230043)

and 8 more cleared under P230043

Similar devices in this category

Other devices filed under Laboratory instrument/analyser application software IVD.

Other devices from Exact Sciences Corporation

See all devices from Exact Sciences Corporation →

Properties

  • Prescription use
Other properties (14, all answered No)