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fda_recall · device_recall · high

Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Numb…

Event date
2026-08-05 00:00:00Z
Observed
2026-08-12 04:20:21Z
Source ID
Z-2825-2026
Payload hash
c28a6f147b83ab8cfffbea59…

Summary

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. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Instrumentation Laboratory had other FDA enforcement actions?
Yes. Argus HQ has recorded 6 total FDA actions tied to Instrumentation Laboratory: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-05; Argus observed and indexed it on 2026-08-12.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Numb…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2825-2026
MLA
"Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Numb…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-instrumentation-laboratory-z-2825-2026.
Chicago
Argus HQ Research. "Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Numb…." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2825-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_instrumentation_laboratory_z_2825_2026_2026,
  title = {Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Numb…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2825-2026},
  note = {Accessed: August 13, 2026}
}

Informational only. Not legal, financial, or medical advice.

Instrumentation Laboratory — Class II recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Numb… · Argus HQ