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GEM Premier 7000 with iQM3

by Instrumentation Laboratory Company United States EUDAMED510(k)GUDID

Ref 00000015279 Product code CHLEMDN W0201040102

Regulatory status

as of 25 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0195226000924R3 Basic UDI-DIDate27 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00195226000924 UDI-DIDate2 Oct 2023ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK223608 Date10 Aug 2023IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Certificates: none listed in EUDAMED

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2899-2026 FDA Class II initiated 21 May 2026

    The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

    • Ongoing Z-2822-2026 FDA Class II initiated 8 May 2026

    Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Blood gas/haemoximetry analyser IVD, laboratory
Model / Reference
00000015279
Primary DI / UDI-DI
00195226000924
Basic UDI-DI
0195226000924R3
Direct Marketing DI
00195226000924
510(k) Number
FDA Product Code
CHL
EMDN Code
W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
GMDN Term
Blood gas/haemoximetry analyser IVD, laboratory
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1120
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000035586
Authorised representative
Instrumentation Laboratory SpA IT-AR-000008169

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Serial Number
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 1bc4aef0-7d8b-4c72-9878-a81a3a153792 61 fields · synced 24 Oct 2026
  • FDA UDI 29a2b89a-9479-4d5c-bfeb-69147f121760 35 fields · synced 30 May 2026
  • FDA 510(k) K223608 1 fields · synced 18 May 2026