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Atellica CH GluH_3
Siemens Healthcare Diagnostics Inc. · Model 11645762 · UDI-DI 00630414654126
1
510(k) clearances
37,534
Adverse events (49 deaths)
22
Recalls
46
Facilities
Description
Glucose Hexokinase ( GluH_3) Atellica CH - RGT 3120T
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.