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
- Laboratory Instrument/Quality Control System
- Model numbers
- Part number: 00055445010, UDI: 08426950807810, Lots No.: 251023N, 251024J, 251114K, 251117A, 251117AC, 251117AE, 251117F, 251117I, 251117J, 251117Y, 251118A, 251119A, 251120U, 251121Q, 251121S, 251121T, 251121W, 251121X
- 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 platform used in laboratories to measure patient samples. It uses GEM PAK cartridges for testing and relies on iQM2 quality control. Typical use includes rapid, automated testing in hospital or reference labs.
Why This Is Dangerous
PCSND errors during warm-up can eject GEM PAK cartridges, delaying test results and potentially impacting patient management.
Industry Context
This recall is part of a broader pattern of QC cartridge reliability issues in clinical analyzers.
Real-World Impact
Delays in results, potential reassessment of patient management, operational disruption for labs.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055445010 or 00055445011.
- Look for UDI 08426950807810 on packaging or labels.
Where to find product info
Recall notice on FDA enforcement page and Instrumentation Laboratory communications.
What timeline to expect
Expect recall resolution and replacements within 4-8 weeks, subject to stock and processing.
If the manufacturer is unresponsive
- Escalate to regulatory affairs department
- Document all outreach attempts
- File complaint with FDA if manufacturer is nonresponsive
How to prevent similar issues
- Audit QC cartridge reliability and warm-up procedures
- Maintain inventory control and safety stock
- Verify lots before use in high-throughput settings
Documentation advice
Preserve lot codes, part numbers, communications, replacement receipts, and test results impacted by delay.
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Product Details
Model numbers: Part No. 00055445010 and 00055445011. Distribution: Worldwide, including US nationwide and many countries listed. Recall date: 2026-01-20. Status: ACTIVE. Quantity: 1,989 units.
Reported Incidents
No specific injury counts provided in the data. The recall note references multiple customer complaints and operational disruption but does not report injuries.
Key Facts
- Worldwide distribution in US and many countries
- PCSND errors during warm-up
- Consecutive ejections may delay results
- Stop-use immediately; contact Instrumentation Laboratory
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Safety Guide
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