Beckman Coulter Inc.: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Agency Publication Date: May 12, 2017

Affected Products

Product: Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

all lots

Product: Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.

all lots

Product: Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.

all lots

Product: Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.

all lots

Product: HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

all lots

Product: Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.

all lots

Product: Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

all lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76962

Status: Resolved

Manufacturer: Beckman Coulter Inc.

Manufactured In: United States

Units Affected: 7 products (92,837 units total (71,271 units in US); 100,286 units total (20,732 units in US); 12,665 units total (1,399 units in US); 128,718 units total (47,858 units in US); 91,996 units total (51,027 units in US); 124,068 units total (47,920 units in US); 50,645 units total (43,816 units in US))

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

all lots

Product: Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.

all lots

Product: Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.

all lots

Product: Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.

all lots

Product: HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

all lots

Product: Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.

all lots

Product: Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

all lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76962

Status: Resolved

Manufacturer: Beckman Coulter Inc.

Manufactured In: United States