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, PREGNANT, PETS
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 PAK cartridge
- Model numbers
- 00055407504, Lot 251111O, 251112P, 251113U, 251114T, 251117AD, 251118D, 251119D +11 more
- 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
GEM Premier 5000 is a clinical chemistry analyzer used in laboratories to run blood gas and chemistry tests.
Why This Is Dangerous
PCSND errors during warm-up can eject a GEM PAK, delaying results and potentially affecting patient management.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Delays in diagnostic results may affect patient management timelines and scheduling.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055407504
Where to find product info
Review device labels, packaging, or supplier communications for lot numbers and UDI.
What timeline to expect
Timeline varies; expect recall communications from IL for refunds/replacements.
If the manufacturer is unresponsive
- Escalate to IL customer support
- Contact FDA for enforcement questions
- File a consumer complaint with CPSC if needed
How to prevent similar issues
- Maintain updated recall contacts
- Audit inventory to isolate affected lots
- Coordinate with clinical teams to manage workflow during warm-up
- Verify AutoPAK Validation status during testing
Documentation advice
Document all communications with IL and clinical impact notes for patients.
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Product Details
Model numbers and lot codes: Part No. 00055407504. Quantity: 489 units. Distribution: Worldwide, including US and listed countries.
Reported Incidents
High hazard level based on 489 units recalled and multiple complaints of PCSND errors during warm-up. No specific injury reports are provided in the summary.
Key Facts
- Global distribution in 60+ countries
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Safety Guide
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