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 Premier 5000 PAK cartridge
- Model numbers
- Part No. 00055360008, UDI: 08426950807575, Lot No. 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E +2 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 benchtop blood gas analyzer used for rapid metabolic and electrolyte testing. GEM PAK cartridges are consumables used within the system to perform the tests.
Why This Is Dangerous
A PCSND error during warm-up can cause a GEM PAK to eject. If an AutoPAK Validation occurs after warm-up, the cartridge may continue to be used, delaying results and potentially affecting patient management.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could cause testing delays in clinical settings and require procedural adjustments to ensure timely patient care.
Practical Guidance
How to identify if yours is affected
- Check Part No. 00055360008 on cartridge label or packaging
Where to find product info
FDA recall enforcement page and the manufacturer recall notice; packaging and device labeling
What timeline to expect
Typically 4-6 weeks for refunds or replacements after dealer/manufacturer coordination
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to manufacturer recall channels and regulatory authorities if needed
How to prevent similar issues
- Verify Part No. 00055360008 before use
- Keep updated on recall notices
- Develop contingency testing plans in labs using GEM Premier 5000
Documentation advice
Preserve recall notices, take photos of cartridge labels and packaging, record serials and lot numbers, save all correspondence
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Product Details
Model numbers/part numbers: 00055360008 (Part No. 00055360008); UDI: 08426950807575; Lot Nos: 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X. Where sold: Worldwide distribution; US nationwide; countries include Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan,
Reported Incidents
Confirmed customer complaints indicate PCSND errors during warm-up with GEM PAK ejection. No specific injuries or fatalities are documented in the recall notice.
Key Facts
- Worldwide distribution including US nationwide
- Part No. 00055360008; UDI 08426950807575
- PCSND errors during warm-up may eject GEM PAKs and delay results
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Safety Guide
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