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 Premier 5000 PAK cartridge (Quality control cartridge)
- Model numbers
- Part number: 00055407511, UDI: 08426950807643, Lots No. 251114K, 251201X, 251215D.
- 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 clinically used analyzer that uses GEM PAK cartridges for quality control. Labs rely on AutoPAK Validation to validate performance.
Why This Is Dangerous
PCSND errors during warm-up can trigger consecutive GEM PAK ejections, delaying results and potentially impacting patient management.
Industry Context
This recall is not a broader industry pattern.
Real-World Impact
Delays in test results and potential reassessment of patient management until results are available.
Practical Guidance
How to identify if yours is affected
- Check Part number 00055407511
- Check lots 251114K, 251201X, 251215D
Where to find product info
Recall notices from Instrumentation Laboratory and FDA enforcement page. Look for product labels showing the part number, UDI, or lot codes.
What timeline to expect
Replacement or remediation timeline is not specified in the notice.
If the manufacturer is unresponsive
- Document communications with the manufacturer.
- Escalate to hospital risk management if needed.
- File a formal complaint with relevant regulators if the vendor is unresponsive.
How to prevent similar issues
- Verify QC cartridge lot and part numbers before use.
- Monitor recall notices from the manufacturer.
- Maintain an updated inventory of GEM PAK cartridges.
Documentation advice
Keep the recall notice, part number, UDI, and lot codes; log all communications with the manufacturer and clinical impact on patient management.
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Product Details
Part number: 00055407511. UDI: 08426950807643. Lots: 251114K, 251201X, 251215D. Distribution: Worldwide, including US and listed countries. Recall date: 2026-01-20. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US and 60+ countries
- Lots 251114K, 251201X, 251215D
- PCSND during warm-up with potential GEM PAK ejections
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Safety Guide
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