The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2825-2026·Announced 2026-08-05

GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported injuries in the source; the potential for incorrect patient ID assignment is a risk-of-harm device issue where injury has not yet been reported, matching the High rubric criterion.

Plain-English summary

Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system, model/catalog number 00024019255, due to a potential problem with the Bar Code Reader (BCR) wand. The affected accessory is the BCR wand, part number 00024015859, UDI 08426950869634, that received a configuration update on or after April 8, 2026. The recall covers 21 units distributed nationwide in the US.

The BCR wand may assign patient results to an incorrect patient ID when used with the GEM Premier 5000 and GEM Premier 7000 systems. This could cause patient results to be associated with the wrong person.

The recall affects the GEM Premier 5000 system with part number 00024019255 and UDI 08426950870227; affected serial numbers are listed in the recall notice. Users should verify whether their system or BCR wand is affected and follow the FDA recall notice for further instructions. The FDA recall number is Z-2825-2026.

The recalled product

Product
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Manufacturer
Instrumentation Laboratory
Category
Medical Device — Blood Analyzer / Point-of-Care
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 18021546
  • 18021549
  • 26012036
  • 18051850
  • 23054764
  • 21068342
  • 25080219
  • 26010781
  • 25122012
  • 25041639
  • 25120558
  • 25079944
  • 25079943
  • 25028719
  • 25100485
  • 25079947
  • 25100483
  • 25100484
  • UDI No. 08426950869634

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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