Agency classClass IIOur severity:High FDA (Devices)·Z-2823-2026·Announced 2026-08-05

Portable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk

Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.

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: This is an FDA Class II recall with no reported injuries in the source. The hazard is a potential risk of harm from incorrect patient ID assignment, which fits the High rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system (Model/Catalog Number 00024019255) because the Bar Code Reader (BCR) wand used with the system may assign patient results to an incorrect patient ID. The affected accessory is the BCR Wand (Part No. 00024015859; UDI 08426950869634) that received a configuration update on or after 8 April 2026. The recall covers 27 units distributed nationwide in the US.

The recall notice also indicates that BCR wands used with GEM Premier 7000 systems may be affected. The FDA has classified this recall as Class II. The notice describes the potential for misassignment but does not include reports of patient harm.

Healthcare providers and users should verify whether their BCR wand is affected by checking the part number, UDI, and configuration update date. The recall notice does not include specific consumer instructions; users should contact Instrumentation Laboratory or consult the FDA recall listing for further guidance.

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 — Point-of-Care Blood Analyzer
Hazard: incorrect-patient-id
barcode-reader-malfunction
Affected units: 27

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 (20)

20106039
19052933
20116415
20064792
22062065
22062067
19103490
22092716
22102881
18112339
19012518
20126582
20075256
20064794
20106036
24016057
21088758
21088759
18061910
24016081

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 →

Same manufacturer · Instrumentation Laboratory

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Same hazard · incorrect patient id