5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 recallZ-2895-2026 · Aniara Diagnostica LLC · initiated Jul 1, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aniara Diagnostica LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2895-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 1, 2026
- Posted by the FDA
- Aug 5, 2026
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 7 units
- Product code
- JIX
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
Product description
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Code information (models, lots, serial numbers)
UDI-DI: 05070002420392, Lot Number: KE132601
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 5-PLASMA Bivalirudin Calibrator 5D-469055-Diagnostics Ltd · Calibrator, Multi-Analyte Mixture1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99344).
- Z-2894-2026 · Open, Classified5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Z-2896-2026 · Open, Classified5-PLASMA Bivalirudin Control, Model Number 5D-44905
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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