Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Calibrator

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

Email notifications were sent to customers on 6/17/26. Please reply to this email as acknowledgment you have received this initial notification and please include the quantity of each product which is remaining in your possession. A notification letter dated 7/1/26 was sent to customers. Actions to be implemented: " Destroy all stock of 5-PLASMA Bivalirudin Control, 5-PLASMA Bivalirudin Calibrator, & 5-PLASMA AMR Verification Kits - Please permanently deface the box labels and vial labels before disposal. " Complete and return the Awareness Acknowledgement form. " If product has been consumed please add brief statement to the Comment section, complete the End User Information, and return the Awareness Acknowledgement form.

• FDA enforcement recordOfficial FDA database entry for Z-2895-2026
• FDA device classification · JIXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1150The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Aniara Diagnostica LLCSearch 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.