Recall Z-2896-2026
Aniara Diagnostica LLC · initiated July 1, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Codes / lots: UDI-DI: 05070002420385, Lot Number: KE132602
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2896-2026
- Initiated
- July 1, 2026
- Posted by FDA
- August 5, 2026
- Product code
- GGN – Plasma, Coagulation Control
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Recalling firm
- Aniara Diagnostica LLC, West Chester, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2894-2026 Class II | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | 07/01/2026Open, Classified |
| Z-2895-2026 Class II | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | 07/01/2026Open, Classified |