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, PREGNANT, PREGNANT
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: 00055407510, UDI: 08426950807636, Lots No.: 251114J, 251117AC, 251117T, 251118B, 251119B, 251121P, 251124O, 251124Q, 251126E, 251201U, 251201V, 251201W, 251202G, 251203H, 251203L, 251204N, 251204O, 251205L
- 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 coagulation and chemistry analyzer used in hospital labs to run patient samples. GEM PAK cartridges are consumables used with the analyzer.
Why This Is Dangerous
PCSND errors during warm-up can cause cartridges to eject, potentially delaying test results and impacting patient care.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Delays in test results and potential reassessment of patient management during the recall period.
Practical Guidance
How to identify if yours is affected
- Check UDI 08426950807636 on packaging or label.
- Verify distribution and purchase history to determine exposure.
Where to find product info
UDI on cartridge label; Lot numbers on packaging; recall notice via FDA enforcement site.
What timeline to expect
No specific refund timeline provided. Expect replacement or instructions per manufacturer communications.
If the manufacturer is unresponsive
- Escalate to hospital supply chain management
- File a recall report with the FDA if necessary
- Seek alternative suppliers for replacements
How to prevent similar issues
- Verify cartridges before use
- Maintain spare GEM PAK inventory
- Monitor for recall updates from Instrumentation Laboratory
- Coordinate with clinical engineering for replacements
Documentation advice
Keep recall notices, order records, replacement receipts, and correspondence with the manufacturer.
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Product Details
Part No. 00055407510. Global distribution. Recall date 2026-01-20. Report date 2026-03-18. Price not disclosed.
Reported Incidents
1,126 units recalled. No injuries or deaths reported in the provided data.
Key Facts
- Global distribution across many countries
- PCSND errors during warm-up may cause GEM PAK ejections
- AutoPAK Validation may allow continued use after warm-up
- High risk to turnaround times and patient management
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Safety Guide
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