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
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
- Blood Gas Analyzer
- Model numbers
- 00055415011, 08426950807704
- 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 clinical analyzer that uses GEM PAK cartridges to run tests. It is used in hospital laboratories to generate diagnostic results.
Why This Is Dangerous
PCSND errors during warm-up may lead to GEM PAK cartridge ejection, potentially delaying test results and affecting patient management decisions.
Industry Context
This recall highlights potential operational disruptions in automated QC processes for clinical analyzers.
Real-World Impact
Delays in test turnaround times may require reassessment of patient management and treatment decisions.
Practical Guidance
How to identify if yours is affected
- Verify model number 00055415011 on the device label.
- Check Lots 251215D.
Where to find product info
Look for Part No, UDI, and Lot numbers on the device label or accompanying documentation.
What timeline to expect
Recall timeline and remediation steps will be provided by IL; no specific timeframe is given here.
If the manufacturer is unresponsive
- Escalate to hospital recall coordinator or risk management.
- Contact IL for official remediation steps if the facility receives guidance via email/letter/phone.
How to prevent similar issues
- Regularly monitor recall notices from IL and FDA for this device.
- Maintain an up-to-date inventory of GEM Premier 5000 units and associated PAK cartridges.
- Train staff on stopping use and initiating recall protocols immediately.
Documentation advice
Preserve the recall notice, record serials, dates of purchase, and correspondence with IL. Document patient impact if any.
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Product Details
Model numbers: 00055415011 (Part No). UDI: 08426950807704. Lots No.: 251215D. Distribution: Worldwide distribution. Sold from unknown dates. Price: Unknown. Quantity: 7 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lots No. 251215D
- PCSND warm-up errors leading to GEM PAK ejections
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Safety Guide
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