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Pointe Glucose Reagent

HORIBA INSTRUMENTS INCORPORATED · Model 16-G7517-528 · UDI-DI 00811727016157

CFR Prescription

510(k) clearances

37,537

Adverse events (49 deaths)

Recalls

Facilities

Description

Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For the in vitro quantitative measurement of glucose in serum.

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.

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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.