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 recall involves a medical device with a high risk of harm due to the potential for incorrect patient identification, though no injuries have been reported in the source text.
Plain-English summary
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands that received a configuration update on or after April 8, 2026. These wands are used with GEM Premier 5000 and GEM Premier 7000 portable blood analyzers.
The recall is due to a potential for the wands to assign patient results to an incorrect patient ID. This issue affects Bar Code Reader (BCR) Wand Part No. 00024015859; UDI No. 08426950869634.
Specific GEM Premier 7000 serial numbers affected include 26012062, 26012065, 26012069, and 26012070.
The recalled product
- Product
- Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
- Manufacturer
- Instrumentation Laboratory
- Category
- Medical Device — Blood Analyzers
- Affected units
- 4
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 (2)
- 26012065
- 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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