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BIOPHEN LMWH Control Plasma

HYPHEN BIOMED · Model 223001 · UDI-DI 03663537008283

GGN
1
510(k) clearances
148
Adverse events
16
Recalls
43
Facilities

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.