Recall Z-2899-2026 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Instrumentation Laboratory
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
| Date | Aug 6, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 5/21/26, the firm began notifying consignees in the US via letter. Consignees were informed that Werfen will be proactively shipping replacement PAKs to each facility. Customers were instructed to check inventory for affected product. They should discontinue use of the affected lots and destroy any inventory on hand. Destruction should be documented via the response form provided to the customer and returned to the recalling firm. Customers should forward the notification to all affected locations at each facility. On May 28, 2026, the field action was expanded to include affected c |
| Quantity | 32 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223608 | GEM Premier 7000 with IQM3 Instrumentation Laboratory Company, Aug 10, 2023 |