Recall Z-2894-2026 ยท JIT Calibrator, Secondary
Aniara Diagnostica LLC
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
| Date | Aug 5, 2026 (initiated Jul 1, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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 cons |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of IL, NC, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.