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, PREGNANT, PREGNANT
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 Clinical Chemistry Analyzer
- Model numbers
- 00055430010, 08426950807759
- 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
The GEM Premier 5000 is a clinical laboratory analyzer used in hospitals and labs to run quality control cartridges known as GEM PAKs.
Why This Is Dangerous
During warm-up, PCSND errors may occur, causing GEM PAKs to eject. If an AutoPAK Validation completes, the cartridge may remain in use, potentially delaying results and affecting patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Labs may face turnaround delays and need to reassess patient management for affected runs until issues are resolved.
Practical Guidance
How to identify if yours is affected
- Confirm device is GEM Premier 5000
- Check Part Number 00055430010
- Review GEM PAK lot numbers listed in the recall
Where to find product info
GEM PAK labels and device documentation display the lot numbers, UDI, and model numbers.
What timeline to expect
4-8 weeks for refund or replacement processing after notification, per typical recall timelines.
If the manufacturer is unresponsive
- Escalate with IL recall management
- File a complaint with appropriate regulatory body if necessary
- Seek alternative QC methods temporarily as advised by your facility's biosafety officer
How to prevent similar issues
- Monitor for recall notices and update lab inventory with affected lot numbers
- Maintain an alternate QC strategy during remediation
- Verify software and QC programs (iQM2) are up to date as advised by IL
Documentation advice
Document all communications with IL, notices received, unit serials, lot numbers, and affected results during the recall period
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,607 units recalled worldwide
- Hazard: PCSND errors during warm-up leading to GEM PAK ejection; 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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