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
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
- 00055360004
- 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
The GEM Premier 5000 is a clinical chemistry analyzer used for patient testing. GEM PAK cartridges are consumables that perform specific tests within the instrument.
Why This Is Dangerous
PCSND errors during warm-up can cause GEM PAKs to eject. If AutoPAK Validation completes, the cartridge may remain in use, potentially delaying results and impacting patient management.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Affects labs and facilities using the GEM Premier 5000; delays in test results can affect timely patient care and decision-making.
Practical Guidance
How to identify if yours is affected
- Verify Part No. 00055360004 on the cartridge label
Where to find product info
Cartridge label and packaging for Part No. 00055360004
What timeline to expect
No specific remediation timeline provided; follow manufacturer instructions for replacement process
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to CPSC or regulatory body if the company is unresponsive
- Seek interim guidance from your hospital or lab management
How to prevent similar issues
- Do not purchase or use cartridges outside the listed lot numbers
- Maintain inventory controls to ensure quick access to replacement lots
- Verify cartridge compatibility with GEM Premier 5000 before use
Documentation advice
Keep records of all recall notifications, cartridge batch numbers, and communications with the manufacturer
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Product Details
Product: GEM Premier 5000 PAK cartridge Part No.: 00055360004 UDI: 08426950899662 Lot Nos.: 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X Sold worldwide, including US nationwide and numerous countries listed by the FDA recall Recall date: 2026-01-20 Status: ACTIVE Quantity recalled: 51 units Manufacturer: Instrumentation Laboratory Categories: Health & Personal Care, Medical Devices Model/Part family: GEM Premier 5000 PAK cartridge
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US Nationwide and many countries
- High-risk hazard level; device may cause operational disruption
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