Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.
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: The hazard involves a high-risk error (misidentifying patient data) that could lead to significant harm, though no injuries have been reported in the source text.
Plain-English summary
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands (Part No. 00024015859) that received a configuration update on or after April 8, 2026. These wands are used with the GEM Premier 5000 with IQM2 (Model 00024019255) and GEM Premier 7000 with iQM3 (Model 00000015279) portable blood analyzer systems.
The recall was initiated because there is a potential for the wands to assign patient results to an incorrect patient ID. This error could lead to medical results being associated with the wrong patient.
This recall affects 122 units distributed nationwide in the US. Users should follow manufacturer instructions regarding the affected accessory.
The recalled product
- Product
- GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 122
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 (3)
- GEM Premier 5000 Part number: 00024019255
- UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279
- 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.
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