GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 000...
FDA Device Recall #Z-2900-2026 - Class II, May 21, 2026
Recall Summary
| Recall Number | Z-2900-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 21, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumentation Laboratory |
| Location | Bedford, MA |
| Product Type | Devices |
| Quantity | 109 units |
Product Description
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Reason for Recall
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
Lot / Code Information
Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;
Other Recalls from Instrumentation Laboratory
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2899-2026 | Class II | GEM Premier 7000 with iQM3 Part Numbers: ... | May 21, 2026 |
| Z-2822-2026 | Class II | Brand Name: GEM Premier 7000 with iQM3 Product ... | May 8, 2026 |
| Z-2825-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM... | May 8, 2026 |
| Z-2824-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM... | May 8, 2026 |
| Z-2823-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM... | May 8, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.