Instrumentation Laboratory recalls GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 000554…

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.

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

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 customers in China. On June 23, 2026, the field action was expanded to include additional affected lots in Italy and Germany.

• FDA enforcement recordOfficial FDA database entry for Z-2900-2026
• FDA 510(k) clearance · K203790The device's official FDA premarket clearance record
• FDA device classification · CHLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1120The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Instrumentation LaboratorySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.