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 PAK cartridge for GEM Premier 5000
- Model numbers
- Part number: 00055407508, UDI: 08426950807612, Lots No.: 251021P, 251106X, 251110AF, 251201AJ, 251202P, 251209S +9 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
GEM Premier 5000 is a blood testing analyzer that uses GEM PAK cartridges for testing. The iQM2 program monitors the testing process, and AutoPAK Validation may allow a cartridge to remain in use after warm-up if validation completes.
Why This Is Dangerous
A PCSND error during warm-up can cause consecutive ejections of GEM PAK cartridges, delaying test results and potentially impacting patient management.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The issue can disrupt lab turnaround times and patient management decisions, creating operational challenges for healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Review the lot numbers listed in the recall notice.
- Verify part number 00055407508 on your GEM PAK cartridges.
- Confirm UDI 08426950807612 on the cartridge label.
Where to find product info
Cartridge packaging and device software/logs typically display the part number, UDI, and lot codes.
What timeline to expect
Recall processing and replacements may take several weeks; facilities should plan accordingly (typical 4-8 weeks).
If the manufacturer is unresponsive
- Escalate to hospital procurement or biomedical engineering leadership.
- File a report with the FDA if appropriate per local policy.
How to prevent similar issues
- Use only cartridges from authorized distributors.
- Maintain an up-to-date inventory by lot and serial numbers.
- Verify recall status before deploying cartridges in patient testing.
Documentation advice
Keep records of all affected lot numbers, correspondence with the manufacturer, and any test result delays or patient management changes.
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Product Details
Model numbers and lot information are provided in the recall. Distribution is worldwide, including the US and numerous countries.
Reported Incidents
Confirmed customer complaints indicate PCSND errors during warm-up with consecutive GEM PAK ejections. No injuries or deaths are specified in the recall notice.
Key Facts
- 251223E, 251223M, 251223P, 251229X, 260102F
- Hazard: PCSND errors during warm-up causing GEM PAK ejection
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Safety Guide
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