Home › Affinity Biologicals Inc › VisuCon-L Coag Screen ABN1 Plasma

VisuCon-L Coag Screen ABN1 Plasma

Affinity Biologicals Inc · Model LCSAB101 · UDI-DI 10629009101104

GGN

510(k) clearances

148

Adverse events

Recalls

Facilities

Description

A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range.

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
2026-04-30	Accriva Diagnostics, Inc.	Assayed Whole blood control contains labeling with incorrect performance range.
2022-06-28	Aniara Diagnostica LLC	Incorrect product labeling was included in the package.
2019-11-18	Diagnostica Stago, Inc.	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for fact
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2016-02-18	TEM Systems Inc	Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 201
2013-11-15	Instrumentation Laboratory Co.	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
2013-11-15	Instrumentation Laboratory Co.	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

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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.