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 Chemistry Analyzer Cartridge (GEM PAK)
- Model numbers
- GEM Premier 5000, Part No. 00055430008, UDI: 08426950807735, Lots 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, 251230P
- 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 that uses GEM PAK cartridges to perform assays in medical settings.
Why This Is Dangerous
PCSND errors during warm-up can cause GEM PAK ejections, delaying test results and affecting patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Delays in results and potential need for reassessment of patient management during outages.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055430008 on GEM PAK cartridges
Where to find product info
FDA recall page and Instrumentation Laboratory recall communications
What timeline to expect
Manufacturer advises stopping use now; replacement or refund timelines to be provided by Instrumentation Laboratory
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital compliance or risk management
- Contact FDA/Regulator if no resolution
How to prevent similar issues
- Establish a contingency plan for instrument downtime
- Regularly review QC procedures during warm-up
- Verify cartridges are from authorized lots before use
Documentation advice
Keep copy of recall notice, lot numbers, procurement records, and communications with the manufacturer
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Reported Incidents
The recall cites confirmed customer complaints of PCSND errors during warm-up with consecutive ejections. No specific injuries or fatalities are described in the documentation.
Key Facts
- PCSND errors during warm-up
- Possible GEM PAK ejection during AutoPAK Validation
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Safety Guide
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