Quick Facts at a Glance
- Recall Date
- January 20, 2026
- Hazard Level
- HIGH
- Brand
- Instrumentation Laboratory
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 PAK cartridge for GEM Premier 5000
- Model numbers
- 00055415010, UDI 08426950807698
- Sold at
- Multiple Retailers
- 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
GEM Premier 5000 is a clinical chemistry analyzer that uses GEM PAK cartridges to run patient samples in hospital or reference labs.
Why This Is Dangerous
During warm-up, PCSND errors can trigger GEM PAK ejections and require insertion of a new PAK, potentially delaying results.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Delays in test turnaround can affect patient management and decision-making in clinical settings.
Practical Guidance
How to identify if yours is affected
- Verify part number 00055415010 on your GEM Premier 5000 cartridges.
- Check UDI 08426950807698 on the cartridge packaging or device label.
Where to find product info
Recall details are available on the FDA enforcement page linked in the notice and the manufacturer recall notification.
What timeline to expect
Remedy timelines vary; replacements or service are typically processed within weeks once the recall is executed.
If the manufacturer is unresponsive
- Keep records of all communications
- Escalate to regulatory authorities if the vendor remains unresponsive
- Consult hospital risk management for interim testing policies
How to prevent similar issues
- In future procurements, verify device recall status and UDI compatibility
- Maintain a current inventory of all cartridge lots and associated lot numbers
- Establish a recall response plan with your clinical lab team
Documentation advice
Document cartridge lot numbers, UDI, purchase records, and all recall communications; retain imaging of the device label and cartridge packaging.
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Product Details
Model numbers: 00055415010 (Part No.) UDI: 08426950807698 Lots: 251114J, 251114K, 251114L, 251117AA, 251117F, 251117I, 251117L, 251117T, 251118A, 251118B, 251118C, 251119A, 251119B, 251124K, 251126D, 251126M, 251126N, 251126U Sold at: Worldwide distribution including US nationwide and many countries listed in recall notice Price: Unknown Status: Active recall Recall date: 2026-01-20 Distributor: Instrumentation Laboratory Product: GEM Premier 5000 chemistry analyzer cartridges
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,629 units recalled worldwide
- GEM PAKs ejected during warm-up
- PCSND errors may delay results
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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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