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 Cartridge System
- Model numbers
- 00055430011, 08426950807766, 251114K, 251205K, 251215D
- 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 hospital blood gas analyzer that uses GEM PAK cartridges to measure critical blood gas and chemistry parameters.
Why This Is Dangerous
A warm-up defect can cause PCSND errors and consecutive cartridge ejections. If AutoPAK Validation completes, the cartridge may continue to be used, prolonging disruption in testing.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience longer turnaround times for blood gas results and may need to reassess patient management while the issue is unresolved.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055430011 on the cartridge or device label.
- Verify lot numbers 251114K, 251205K, 251215D on cartridges.
Where to find product info
Cartridge labels and packaging include Part No., UDI, and lot numbers. Recall notices provide details.
What timeline to expect
Replacement or remediation timelines will be provided by the manufacturer; expect weeks to a couple of months in typical recalls.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to hospital safety/compliance teams if needed.
- Consider reporting to the FDA or equivalent regulator if the manufacturer is unresponsive.
How to prevent similar issues
- Verify UDI and lot numbers before deploying new cartridges.
- Follow manufacturer instructions for quality control and validation.
- Maintain advance planning for cartridge substitutions in critical care labs.
Documentation advice
Keep a log of cartridge lot numbers, dates of use, and any PCSND events. Save recall notices and manufacturer correspondence.
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Product Details
Part No. 00055430011. UDI: 08426950807766. Lots: 251114K, 251205K, 251215D. Distribution: Worldwide to healthcare facilities. Sold since unknown date. Price: Unknown.
Reported Incidents
Confirmed customer complaints describe increased PCSND errors during warm-up with consecutive ejections. No injury counts are provided in the recall notice.
Key Facts
- Lots 251114K, 251205K, 251215D
- Worldwide distribution to healthcare facilities
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Safety Guide
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