5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which involves a remote possibility of adverse health consequences, and involves a low-risk contamination/stability issue.
Plain-English summary
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control, Model Number 5D-44905, due to identified stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix.
These stability issues can lead to the degradation of measurable bivalirudin within the controls, calibrators, and linearity values. This affects 9 units distributed nationwide in the states of IL, NC, and TN.
Users should check their inventory for the affected lot number and contact the manufacturer for further guidance.
The recalled product
- Product
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 05070002420385
- Lot Number: KE132602
Distribution
Part of a larger recall action
This product is one of 3 recalled by Aniara Diagnostica LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Aniara Diagnostica LLC
See all →- ModerateAniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
FDA (Devices) · 2026-08-12
- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- ModerateZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
FDA (Devices) · 2026-05-20
- ModerateBIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
FDA (Devices) · 2023-03-15
- LowBIOPHEN UFH Control Plasma Includes Incorrect Product Labeling in Package
FDA (Devices) · 2022-09-21
Same hazard · stability issue
See all →- HighInjectable Drug Recalled for Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- ModerateMedline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling
FDA (Devices) · 2024-02-28
- ModerateZydus oxybutynin extended-release tablets recalled nationwide for failed stability testing
FDA (Drugs) · 2023-11-15
- ModerateClobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability
FDA (Drugs) · 2023-06-07
- ModerateFluocinonide Gel Recalled for Manufacturing Process Deviations
FDA (Drugs) · 2022-03-30
Similar recalls
- HighAngiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
FDA (Devices) · 2018-06-20
- ModerateAniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits
FDA (Devices) · 2019-08-28
- LowAniara Diagnostica Recalls BIOPHEN UFH Control C1 Due to Incorrect Instructions
FDA (Devices) · 2019-04-24
- LowBIOPHEN UFH Control Plasma Includes Incorrect Product Labeling in Package
FDA (Devices) · 2022-09-21
- HighAngiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxins
FDA (Devices) · 2018-06-20
- ModerateAniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues
FDA (Devices) · 2019-08-28