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GEM Premier 5000

by Instrumentation Laboratory Company United States EUDAMED510(k)GUDID

Ref 00024019255

Product code CHLEMDN W0201040102

Regulatory status

as of 24 Oct 2026

Recall ongoing. 26 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number84269508702279D Basic UDI-DIDate15 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK203790 Date20 Aug 2021IssuedStatusActive
United StatesGUDID listing GUDID Number08426950870227 UDI-DIDate29 Mar 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United 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
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Certificates: none listed in EUDAMED

Recalls

26 recalls · 26 ongoing · FDA

    • Ongoing Z-2900-2026 FDA Class II initiated 21 May 2026

    The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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.

  • 5 recalls, same reason

    • Ongoing Z-2823-2026 FDA Class II initiated 8 May 2026
    • Ongoing Z-2825-2026 FDA Class II initiated 8 May 2026
    • Ongoing Z-2824-2026 FDA Class II initiated 8 May 2026
    • Ongoing Z-2826-2026 FDA Class II initiated 8 May 2026
    • Ongoing Z-2821-2026 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.

  • 20 recalls, same reason

    • Ongoing Z-1529-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1533-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1524-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1530-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1541-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1536-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1528-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1526-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1525-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1542-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1535-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1531-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1540-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1543-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1532-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1539-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1534-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1538-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1527-2026 FDA Class II initiated 20 Jan 2026
    • Ongoing Z-1537-2026 FDA Class II initiated 20 Jan 2026

    Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

Specification

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

Generic Name
Blood gas/haemoximetry analyser IVD, laboratory
Model / Ref / Catalog
00024019255
Primary DI / UDI-DI
08426950870227
Basic UDI-DI
84269508702279D
Direct Marketing DI
08426950870227
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

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • 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

Sources (3)

  • EUDAMED 6992b4b0-f8d9-4b7e-bb57-29244896f99b 61 fields · synced 24 Oct 2026
  • FDA UDI d143acfd-3198-46f1-aadf-a69f9bce2e11 36 fields · synced 30 May 2026
  • FDA 510(k) K203790 1 fields · synced 18 May 2026