Blood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID
Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.
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. The hazard is a potential misassignment of patient results, so it falls under 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 systems are identified by serial numbers 25100466, 24097933, and 23064897. The affected accessory is the BCR wand (Part No. 00024015859; UDI 08426950869634) that received a configuration update on or after April 8, 2026.
The recall notice states the BCR wands are used with GEM Premier 5000 and GEM Premier 7000 systems. The FDA has classified this as a Class II recall. The notice does not report any illnesses or injuries.
The potential failure could cause a patient's test results to be assigned to the wrong patient ID, which could lead to incorrect clinical decisions. Healthcare facilities using the affected systems or wands should review the recall notice and contact Instrumentation Laboratory for guidance on identifying affected devices and next steps.
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
- patient-id-mismatch
- 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 (1)
- UDI No. 08426950869634
Distribution
Distributed nationwide across the United States.
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