Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Agency Publication Date: May 11, 2016

Affected Products

Product: Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

Cholesterol_2 (CHOL2): 74719 Cholesterol_concentrated (CHOL_c): 74718

Product: Advia Chemistry Assay: LDL Cholesterol, Direct

Device Listing: LDL Cholesterol, Direct: D126056; Catalog # 74028

Product: Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Device Listing: Direct HDL Cholesterol: D126055; Catalog # 74073

Product: ADVIA CHEMISTRY ENZYMATIC CREATININE_2

Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330

Product: ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721

Product: Advia Chemistry Assay: Lactate

Lactate: E103611, Catalog # (LAC) 74051

Product: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

Device Listing: D126071, Triglyceride_2, Catalog # 74082 Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084

Product: Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

Device Listing: Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated (UA_c) - D033081, Catalog # 74715

Product: Dimension Assays: Direct HDL Cholesterol (AHDL)

Device Listing: D 044702 - Direct HDL Cholesterol (AHDL), Catalog # DF48B

Product: Dimension Assays: ENZYMATIC CREATININE

Device Listing: D089144(Enzymatic Creatine (ECRE) Catalog # DF270B

Product: Dimension Assays: Triglycerides (TGL)

Device Listing: D011286 Triglycerides (TGL), Catalog # DF69A

Product: Dimension Assays: Uric Acid (URCA)

Device Listing: D011436 Uric Acid (URCA), Catalog # DF77

Product: Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A

Product: Dimension Vista Assays: Enzymatic Creatine (ECRE)

Device Listing: D089144 Enzymatic Creatinine (ECRE), Catalog # K1270A

Product: Dimension Vista Assays: Triglycerides (TRIG)

Device Listing: D011436 - Triglycerides (TGL), Catalog # DF69A

Product: Dimension Vista Assays: Uric Acid (URCA)

Device Listing: D011436 - Uric Acid (URCA), Catalog # K1077

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73667

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Manufactured In: United States

Units Affected: 16 products (137422 units total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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