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.
What this means for you
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
- Hazard
- incorrect-patient-id
- barcode-reader-malfunction
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.
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