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
- Blood Gas and Chemistry Analyzer
- Model numbers
- Part number: 00055415008, UDI: 08426950807674, Lots No. 251021P, 251106X, 251110AF, 251111O, 251113J, 251113V +12 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
The GEM Premier 5000 is a laboratory analyzer used in clinical settings to measure blood parameters. It uses GEM PAK cartridges and is monitored by the iQM2 quality control program.
Why This Is Dangerous
During warm-up, GEM PAKs may generate PCSND errors, causing cartridge ejections. This can disrupt testing and delay results.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Labs may experience onboarding delays and test turnaround time increases. Patient management decisions may be affected if results are delayed.
Practical Guidance
How to identify if yours is affected
- Verify Part No. 00055415008.
Where to find product info
Serial numbers, date codes, and lot numbers typically appear on the device label and the GEM PAK cartridges.
What timeline to expect
No timeline is provided for refunds or service in the notice. IL will issue further guidance.
If the manufacturer is unresponsive
- Escalate to hospital administration or risk management.
- Document all communications and file a formal recall request with IL.
How to prevent similar issues
- Maintain up-to-date recall communications.
- Ensure all GEM Premier 5000 units are checked against the recall list.
- Coordinate with IT and quality teams to adjust testing workflows during remediation.
Documentation advice
Keep recall notices, serial numbers, lot numbers, and all correspondence with IL and regulators.
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Product Details
Model numbers: Part No. 00055415008. Distribution: Worldwide to healthcare providers. Sold From: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- PCSND errors during warm-up
- GEM PAK ejections may delay results
- iQM2 quality control program monitors testing process
- Worldwide distribution to US and 60+ countries
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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