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
- Model numbers
- 00055445008, 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q +1 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 laboratory testing system that uses GEM PAK cartridges to perform certain assays in healthcare settings. The device is used to support clinical decision making and patient management.
Why This Is Dangerous
PCSND errors during warm-up can cause cartridge ejection. If AutoPAK Validation completes after warm-up, the GEM PAK may remain in use, potentially delaying test results and impacting patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consecutive ejections may disrupt workflow and delay critical results in clinical settings. Hospitals and labs may need advance planning to minimize impact.
Practical Guidance
How to identify if yours is affected
- Verify part number 00055445008 on the cartridge packaging.
Where to find product info
Recall details are available from Instrumentation Laboratory and the FDA enforcement page linked in the recall notice. Check packaging and labeling for part number and UDI.
What timeline to expect
No specific timeline for refunds or replacements is provided in the notice.
If the manufacturer is unresponsive
- Escalate to Instrumentation Laboratory for guidance.
- Contact your hospital administrator or the local regulatory authority if the manufacturer is unresponsive.
How to prevent similar issues
- Regularly check for recalls on laboratory equipment.
- Record all lot numbers and serial numbers when ordering consumables.
- Establish a protocol for urgent replacements when QC materials require repeated warm-up steps.
Documentation advice
Keep copy of recall notice, packaging, lot numbers, and any correspondence with the manufacturer for records.
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Product Details
Part Number: 00055445008. UDI: 08426950807797. Lots: 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, 251215K. Quantity: 70 units. Sold worldwide, including US nationwide and listed countries. Model reference includes Part number and lot codes associated with GEM Premier 5000 GEM PAK cartridges.
Reported Incidents
The recall cites confirmed customer complaints of PCSND errors during warm-up and ensuing GEM PAK ejections. No specific injury data is provided in the notice.
Key Facts
- 70 total recalled units
- Worldwide distribution including US nationwide and many countries
- Hazard: PCSND errors during warm-up causing cartridge ejection
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Safety Guide
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