Z-2895-2026Class II

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Name: Z-2895-2026 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Creator: Aniara Diagnostica LLC
Published: 2026-07-01
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2026-07-01 / Open, Classified / root cause: manufacturing process

FDA source

Aniara Diagnostica LLC began a recall of 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 on 2026-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2895-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-01
Posted: 2026-08-05
Recalling firm: Aniara Diagnostica LLC
Product: 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA 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 consumed please add brief statement to the Comment section, complete the End User Information, and return the Awareness Acknowledgement form.
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the states of IL, NC, TN.
Product codes and lots: UDI-DI: 05070002420392, Lot Number: KE132601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2895-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2894-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2895-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2896-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code JIX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)