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Open, Classified

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

FDA Recall Z-2894-2026 · Posted 2026-08-05

Recalling FirmAniara Diagnostica LLC
Recall StatusOpen, Classified
Product CodeJIT
Date Initiated2026-07-01
Product Quantity4 units

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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