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 PAK cartridge for GEM Premier 5000
- Model numbers
- Part number: 00055445004, UDI: 08426950807773, Lots No.: 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T +8 more
- 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 laboratory analyzer used for clinical testing. It utilizes GEM PAK cartridges and AutoPAK Validation to monitor testing processes.
Why This Is Dangerous
PCSND errors during warm-up may cause GEM PAKs to eject. Subsequent use of a cartridge after an ejection can delay test results and affect patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Laboratories may experience slower turnaround times and need to reassess patient management while awaiting results.
Practical Guidance
How to identify if yours is affected
- Check if you own GEM Premier 5000 with Part No. 00055445004.
- Review the UDI 08426950807773 and lot numbers listed in the recall.
- Inspect cartridges for PCSND-related ejection history.
Where to find product info
Recall notices and lot-specific instructions are available through the FDA enforcement page and issuer communications from Instrumentation Laboratory.
What timeline to expect
Typical recall remedy processing may take several weeks (the standard window is 4-8 weeks for refunds or replacements).
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement leadership.
- File a formal recall complaint with the manufacturer if no response is received within the stated timeframe.
How to prevent similar issues
- Only use cartridges from non-listed lots if confirmed safe by the manufacturer.
- Keep inventory segregated to prevent use of recalled lots.
- Monitor for recall updates from Instrumentation Laboratory and FDA.
Documentation advice
Retain copies of recall notices, lot numbers, replacement receipts, and communications with the manufacturer.
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Product Details
Model numbers: Part number 00055445004. UDI: 08426950807773. Lots: 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 251229AG, 251229X, 251230P. Distribution: Worldwide (US nationwide and numerous countries). Sold since unknown. Price: Unknown.
Reported Incidents
Confirmed customer complaints describe PCSND errors and GEM PAK ejections during warm-up. No injuries or incidents are detailed in the recall summary.
Key Facts
- Worldwide distribution including US and 50+ countries
- GEM PAK ejections during warm-up may delay results
- AutoPAK Validation after warm-up may allow continued use of the cartridge
- Manufacturer: Instrumentation Laboratory
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Safety Guide
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