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Corded 2D Barcode Imager

by Instrumentation Laboratory Company United States EUDAMEDGUDID

Ref 00024015859 Product code CHLEMDN W0201040180

Regulatory status

as of 25 Oct 2026

Recall ongoing. 26 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8426950869634BJ Basic UDI-DIDate15 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950869634 UDI-DIDate29 Mar 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

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 · GUDID · synced 22 Oct 2026

Trade Name
Corded 2D Barcode Imager EUDAMED
Wand, Bar Code GUDID
Generic Name
Barcode reader
Model / Ref / Catalog
00024015859
Primary DI / UDI-DI
08426950869634
Basic UDI-DI
8426950869634BJ
Direct Marketing DI
08426950869634
510(k) Number
FDA Product Code
CHL
EMDN Code
W0201040180 Blood gas analysers - hardware accessories
GMDN Term
Barcode reader
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
  • Prescription Use
  • Convenience Kit
  • 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
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED a9f0bf2b-e578-45f5-b4a7-a1c20e21df83 61 fields · synced 22 Oct 2026
  • FDA UDI c9d075d9-b43a-4633-add7-7574bacd8a80 36 fields · synced 30 May 2026