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.

.hq

fda_recall · device_recall · high

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

Name: FDA Recall Record — Instrumentation Laboratory
Creator: Argus HQ
Published: 2026-08-05
License: https://argushq.ai/methodology

Event date: 2026-08-05 00:00:00Z
Observed: 2026-08-12 04:20:21Z
Source ID: Z-2823-2026
Payload hash: 537a71222be8775f038cf9fe…

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

Instrumentation Laboratory

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-2823-2026

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-2823-2026.

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-2823-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_instrumentation_laboratory_z_2823_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-2823-2026},
  note = {Accessed: August 13, 2026}
}

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