Home › CLINICAL DIAGNOSTIC SOLUTIONS, INC. › Glucose Reagent

Glucose Reagent

CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model 500mL · UDI-DI 00812137011985

CFR

510(k) clearances

37,534

Adverse events (49 deaths)

Recalls

Facilities

Description

For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders.

Recalls

Date	Firm	Reason
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2016-01-11	Horiba Instruments Inc	N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantip
2014-10-23	JAS Diagnostics Inc.	Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
2012-11-28	Mindray DS USA, Inc. d.b.a. Mindray North America	An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
2009-10-19	Pointe Scientific, Inc.	There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
2008-09-10	Pointe Scientific, Inc.	The inability of the product to maintain stated performance specifications through the stated shelf life.
2008-09-10	Pointe Scientific, Inc.	The inability of the product to maintain stated performance specifications through the stated shelf life.
2008-09-10	Pointe Scientific, Inc.	The inability of the product to maintain stated performance specifications through the stated shelf life.
2008-09-10	Pointe Scientific, Inc.	The inability of the product to maintain stated performance specifications through the stated shelf life.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.