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
- Part number: 00055430004, UDI: 08426950807711, Lots No.: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X +12 more
- 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 testing device used in healthcare settings to run certain assays with GEM PAK cartridges. It relies on iQM2 for continuous monitoring during testing.
Why This Is Dangerous
A warm-up PCSND error can eject GEM PAK cartridges, delaying results and potentially impacting patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and labs may experience delays in test results. Backups and re-testing could affect patient flow and management decisions.
Practical Guidance
How to identify if yours is affected
- Check Part number 00055430004
Where to find product info
Cartridge packaging and labels include Part number, UDI, and lot numbers.
What timeline to expect
Replacement or remediation timelines vary; expect weeks for processing after confirmation.
If the manufacturer is unresponsive
- Escalate to facility safety officer
- Request written guidance from IL
- File a recall report with the local health authority if needed
How to prevent similar issues
- Implement inventory controls to isolate affected lots
- Establish a replacement workflow with IL
- Validate all testing proceeds with non-affected cartridges only
Documentation advice
Keep recall notices, inventory lists, and correspondence with IL; document testing delays and actions taken
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 253 units recalled worldwide
- Part number 00055430004; UDI 08426950807711
- Hazard: PCSND errors during warm-up may eject GEM PAKs and delay results
- No injuries or incidents reported
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Safety Guide
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