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
- Model numbers
- 00055360010, 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O +11 more
- 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 hospital/clinical laboratory analyzer that uses GEM PAK cartridges for testing.
Why This Is Dangerous
During warm-up, PCSND errors can cause cartridge ejection and may delay results, impacting patient management.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Operational delays in test results and potential need for reassessment of patient management while awaiting results.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055360010 on GEM PAK cartridges
Where to find product info
Refer to the FDA enforcement page and the manufacturer’s recall notices for identifiers and instructions
What timeline to expect
Remedy processing may take weeks; typical timeframe cited is 4-8 weeks for replacement or refunds where applicable
If the manufacturer is unresponsive
- Document all outreach attempts to Instrumentation Laboratory
- Escalate to hospital risk management or compliance
- File a recall complaint with the FDA if the company remains unresponsive
How to prevent similar issues
- Maintain strict lot-number tracking for PAK cartridges
- Train staff on warm-up procedures and monitor alerts with iQM2
- Verify compatibility of PAK cartridges with GEM Premier 5000 before use
Documentation advice
Keep recall notices, batch numbers, UDI, purchase records, and all correspondence with the manufacturer.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,225 units recalled worldwide
- PCSND warm-up errors may cause PAK ejections and result delays
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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