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Pointe Scientific, Inc. Glucose
HORIBA INSTRUMENTS INCORPORATED · Model OG917-396 · UDI-DI 00811727015020
CFR
Prescription
10
510(k) clearances
37,538
Adverse events (49 deaths)
22
Recalls
47
Facilities
Description
Pointe Scientific, Inc. Glucose Reagent is for the in vitro quantitative measurement of glucose in serum. Packaged for use on Olympus Analyzers. 6 x 66ml
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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Get your free API keyRead the docsData 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.