Quick Facts at a Glance
- Recall Date
- January 20, 2026
- Hazard Level
- HIGH
- Brand
- Instrumentation Laboratory
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Product type
- GEM Premier 5000 PAK cartridges
- Model numbers
- Part number: 00055360011, UDI: 08426950807605, Lots No.: 251119A
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 20, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The GEM Premier 5000 is a medical device used for critical diagnostic testing in healthcare settings. Cartridges called GEM PAKs are consumables used within the system.
Why This Is Dangerous
PCSND errors during warm-up can lead to PAK ejection and testing delays. iQM2 continues monitoring, but repeated ejections may disrupt workflows.
Industry Context
This recall is not part of a broader pattern described in the notice.
Real-World Impact
Delays in test results, potential reassessment of patient management, operational disruption.
Practical Guidance
How to identify if yours is affected
- Locate cartridge Part No. 00055360011 on the packaging
- Check UDI 08426950807605 and Lot No. 251119A
- Confirm model in inventory matches the recalled lot
Where to find product info
Manufacturer’s recall notice or FDA enforcement page; contact Instrumentation Laboratory for instructions
What timeline to expect
Refunds or replacements will follow manufacturer guidance, typically within weeks
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management or procurement
- Consider filing a report with the FDA if no remedy is offered within a reasonable period
How to prevent similar issues
- Verify cartridges before use
- Maintain updated recall contacts
- Audit inventory for recalled lots before use
- Follow manufacturer QA processes to detect PCSND early
Documentation advice
Keep purchase receipts, packaging, recall notices, and correspondence with the manufacturer
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Product Details
Product: GEM Premier 5000 PAK; Part No. 00055360011. Quantity: 10 units. Distribution: Worldwide. Recall date: 2026-01-20. Manufacturer: Instrumentation Laboratory. Model/UDI: Part number 00055360011; UDI 08426950807605; Lot No. 251119A.
Reported Incidents
No injury or death data supplied in the available recall notice. The notice cites several customer complaints of PCSND errors and subsequent ejections during warm-up.
Key Facts
- Lot No. 251119A
- High hazard level (PCSND errors)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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