Quick Facts at a Glance
- Recall Date
- January 20, 2026
- Hazard Level
- HIGH
- Brand
- Instrumentation Laboratory
- Category
- Health & Personal Care
- 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 PAK cartridges
- Model numbers
- Part number: 00055415004, UDI: 08426950807650, 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D +12 more
- 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 lab analyzer cartridge system used in clinical chemistry to process tests with PAK cartridges. Clinicians rely on rapid results for patient management.
Why This Is Dangerous
PCSND errors during warm-up may cause cartridge ejections, delaying results and potentially impacting patient treatment decisions.
Industry Context
This recall is not part of a broader industry pattern; it highlights quality control challenges within cartridge-based analyzers.
Real-World Impact
Hospitals may experience workflow delays due to repeated PAK ejections, requiring advance planning and potential resampling.
Practical Guidance
How to identify if yours is affected
- Confirm distribution includes your facility
Where to find product info
UDI on cartridge packaging and the lot number on the label
What timeline to expect
Replacement or refund timelines will be provided by Instrumentation Laboratory per recall notification
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Document all communications
- Contact FDA if no resolution after reasonable period
How to prevent similar issues
- Verify PAK cartridges before use
- Implement enhanced warm-up checks and QC measures
- Establish recall notification protocol with suppliers
Documentation advice
Keep packaging, batch numbers, correspondence, and any affected PAKs as evidence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: GEM Premier 5000 PAK cartridges, Part No. 00055415004. Quantity: 352 units. Distribution: Worldwide, including US nationwide and listed countries. Lots/UDI: UDI 08426950807650; Lots Nos. 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J. Recall date: 2026-01-20. Status: Active. Hazard level: High.
Reported Incidents
No specific incident counts beyond the reported PCSND errors and ejections. The recall cites patient management may require reassessment due to potential delays.
Key Facts
- 352 units recalled worldwide
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.