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, 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 GEM PAK cartridges
- Model numbers
- 00055415005, 251125S, 251201AJ, 251212O, 251218V, 251229X
- 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
GEM Premier 5000 is a point-of-care blood gas and chemistry analyzer used by healthcare facilities. It relies on GEM PAK cartridges for measurements.
Why This Is Dangerous
During warm-up, GEM PAK cartridges may produce PCSND errors leading to cartridge ejection. AutoPAK Validation may allow continued use, potentially delaying results and impacting patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Delays in test results can affect patient care decisions and require reassessment of patient management while awaiting accurate readings.
Practical Guidance
How to identify if yours is affected
- Check part number 00055415005 on the cartridge label.
- Confirm cartridge is GEM PAK used in GEM Premier 5000.
Where to find product info
On the cartridge label and packaging. Manufacturer recall notices provide identification details.
What timeline to expect
No timeline for remedy provided in the release. Recall status is ACTIVE as of 2026-03-18.
If the manufacturer is unresponsive
- Escalate to hospital risk management and the manufacturer for escalation steps.
- File a report with the appropriate regulatory body if guidance is not provided by the manufacturer.
How to prevent similar issues
- Verify cartridge compatibility before use.
- Maintain inventory controls to ensure only current, non-recalled lots are available.
- Train staff on recognizing PCSND error symptoms and proper warm-up procedures.
Documentation advice
Keep copies of all recall communications, log PCSND incidents, and document corrective actions taken.
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Product Details
Model numbers: Part number 00055415005; UDI 08426950807667; Lots Nos. 251125S, 251201AJ, 251212O, 251218V, 251229X. Sold worldwide to healthcare facilities. Price and sold date not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution to healthcare facilities
- High hazard level
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Safety Guide
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