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5-PLASMA Bivalirudin AMR Verification Kit

5-Diagnostics Ltd · Model 5D-45905 · UDI-DI 05070002420378

JIT Prescription

510(k) clearances

365

Adverse events

Recalls

125

Facilities

Description

The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify bivalirudin activity or concentration in human plasma. The kit consists of five levels of plasma-based materials containing defined concentrations of bivalirudin, covering the clinically relevant measurement range of the associated assay. The kit is designed for laboratory use to verify that a coagulation analyzer or assay method performs accurately and linearly across its claimed analytical measuring range for bivalirudin. It is not intended for direct diagnostic use or patient result reporting.

Recalls

Date	Firm	Reason
2026-07-01	Aniara Diagnostica LLC	Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2024-01-31	Randox Laboratories Ltd.	Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Qua
2023-11-21	Ortho-Clinical Diagnostics, Inc.	Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of
2023-07-25	Siemens Healthcare Diagnostics, Inc.	There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be ob
2023-05-08	Ortho-Clinical Diagnostics	Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval
2020-09-22	Siemens Healthcare Diagnostics, Inc.	Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hype

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.