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Pointe Glucose Hexokinase for BS480

HORIBA INSTRUMENTS INCORPORATED · Model 14-G7517-480 · UDI-DI 00811727015846

CFR Prescription

510(k) clearances

37,537

Adverse events (49 deaths)

Recalls

Facilities

Description

Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. 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.