Quick Facts at a Glance
- Recall Date
- May 8, 2026
- Hazard Level
- HIGH
- Brand
- Instrumentation Laboratory
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Instrumentation Laboratory
- Model numbers
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 8, 2026
Reported by FDA DEVICE
August 5, 2026
RecallRadar source check
August 12, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Instrumentation Laboratory or your healthcare provider for instructions. Notification method: Letter
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Full Description
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system. Reason: 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.. Classification: Class II. Quantity: 27. Distribution: US Nationwide distribution.
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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