5-PLASMA Bivalirudin Control, Model Number 5D-44905

FDA device recall Z-2896-2026 · posted 2026-08-05 · Open, Classified

Recall details

Recalling firm

Aniara Diagnostica LLC

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

GGN

Quantity affected

9 units

Distribution

US Nationwide distribution in the states of IL, NC, TN.

Date initiated

2026-07-01

Date posted

2026-08-05

Location

West Chester, OH