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George King CORE Kit

GEORGE KING BIO-MEDICAL, INC · Model 0070 - 30 · UDI-DI 00815696020504

GGN Prescription
10
510(k) clearances
148
Adverse events
16
Recalls
43
Facilities

Description

George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 15 males and 15 females and is intended for use in establishing reference ranges for coagulation assays.

Recalls

DateFirmReason
2026-07-01Aniara Diagnostica LLCStability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin
2026-04-30Accriva Diagnostics, Inc.Assayed Whole blood control contains labeling with incorrect performance range.
2022-06-28Aniara Diagnostica LLCIncorrect product labeling was included in the package.
2019-11-18Diagnostica 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
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2016-02-18TEM Systems IncCustomer 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
2013-11-15Instrumentation Laboratory Co.HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
2013-11-15Instrumentation 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.