Has Instrumentation Laboratory had other FDA enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to Instrumentation Laboratory: 0 warning letters, 8 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 2026-08-12; Argus observed and indexed it on 2026-08-19.

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: GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504…

Name: FDA Recall Record — Instrumentation Laboratory
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:41Z
Source ID: Z-2900-2026
Payload hash: da54ceac4f767ef90ec7e68a…

Summary

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. Status: Ongoing.

Entities

Instrumentation Laboratory

View source record ↗

Frequently asked questions

Has Instrumentation Laboratory had other FDA enforcement actions?: Yes. Argus HQ has recorded 8 total FDA actions tied to Instrumentation Laboratory: 0 warning letters, 8 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 2026-08-12; Argus observed and indexed it on 2026-08-19.
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: GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2900-2026

MLA

"Instrumentation Laboratory — Class II recall: GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-instrumentation-laboratory-z-2900-2026.

Chicago

Argus HQ Research. "Instrumentation Laboratory — Class II recall: GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2900-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_instrumentation_laboratory_z_2900_2026_2026,
  title = {Instrumentation Laboratory — Class II recall: GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-instrumentation-laboratory-z-2900-2026},
  note = {Accessed: August 19, 2026}
}

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