GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.
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: FDA Class II recall with no reported injuries; the hazard is a potential risk of harm (incorrect patient ID assignment) rather than a confirmed injury, matching the High 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). The reason for the recall is a potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
The recall covers 67 units distributed nationwide in the United States. The affected accessory is the BCR wand (part number 00024015859; UDI 08426950869634) that received a configuration update on or after 8 April 2026. The FDA recall notice is classified as Class II.
Users and healthcare facilities should check the recall notice for affected serial numbers and contact Instrumentation Laboratory for instructions. The notice does not include specific consumer action steps; follow the manufacturer's 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
- Affected units
- 67
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)
- 25100462
- 25110522
- 25100472
- 25101897
- 25101920
- 25101931
- 25122029
- 26012032
- 25122030
- 26012033
- 26012043
- 25110523
- 25110536
- 25120550
- 25069638
- 23101109
- 24011137
- 25081799
- 25081797
- 25091839
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 →Related recalls
Same manufacturer · Instrumentation Laboratory
See all →- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- HighBlood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID
FDA (Devices) · 2026-08-05
Similar recalls
- HighBlood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
FDA (Devices) · 2023-11-29
- HighRadiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation
FDA (Devices) · 2020-04-29
- HighSiemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
FDA (Devices) · 2013-11-06
- ModeratePerkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label
FDA (Devices) · 2016-01-20
- ModeratePerkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
FDA (Devices) · 2016-01-20
- HighSiemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06